Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT03367793
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2017-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Spectacles for Patients With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015354', 'term': 'Vision, Low'}], 'ancestors': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anderson.3881@osu.edu', 'phone': '614-247-5825', 'title': 'Dr. Heather Anderson, Study PI', 'organization': 'Ohio State University College of Optometry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the time of dispense of the first treatment through follow up of the final dispensed treatment (6 months total).', 'description': 'Parents/guardians of participants were contacted by phone one day and one week after each new treatment was dispensed to inquire whether participants were having any difficulty with the glasses. At every visit, participants and their family member were asked if there had been any medical or medication changes since the last visit and if they had any concerns about the spectacles or any new ocular or visual complaints. Reports of glasses needing a fit adjustment were not considered AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Clinical', 'description': 'Spectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 7, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metric #1', 'description': "Spectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 5, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Metric #2', 'description': "Spectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt).", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vision complaint related to comparison with earlier randomized treatment or habitual spectacles', 'notes': 'Patients reporting blur at a particular viewing distance, not liking glasses as well as previous ones, or changing glasses wear behavior.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Symptoms', 'notes': 'Reports of cough or runny nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adapted Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical, Then Metric #1, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG001', 'title': 'Clinical, Then Metric #2, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG002', 'title': 'Metric #1, Then Clinical, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG003', 'title': 'Metric #2, Then Clinical, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG004', 'title': 'Metric #1, Then Metric #2, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG005', 'title': 'Metric #2, Then Metric #1, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}], 'classes': [{'title': 'Period 2 Treatment 1 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.256', 'spread': '0.110', 'groupId': 'OG000'}, {'value': '0.440', 'spread': '0.240', 'groupId': 'OG001'}, {'value': '0.356', 'spread': '0.149', 'groupId': 'OG002'}, {'value': '0.284', 'spread': '0.089', 'groupId': 'OG003'}, {'value': '0.300', 'spread': '0.163', 'groupId': 'OG004'}, {'value': '0.364', 'spread': '0.048', 'groupId': 'OG005'}]}]}, {'title': 'Period 3 Treatment 2 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.272', 'spread': '0.135', 'groupId': 'OG000'}, {'value': '0.412', 'spread': '0.215', 'groupId': 'OG001'}, {'value': '0.370', 'spread': '0.093', 'groupId': 'OG002'}, {'value': '0.316', 'spread': '0.157', 'groupId': 'OG003'}, {'value': '0.256', 'spread': '0.344', 'groupId': 'OG004'}, {'value': '0.316', 'spread': '0.091', 'groupId': 'OG005'}]}]}, {'title': 'Period 4 Treatment 3 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0.288', 'spread': '0.100', 'groupId': 'OG000'}, {'value': '0.424', 'spread': '00.238', 'groupId': 'OG001'}, {'value': '0.320', 'spread': '0.117', 'groupId': 'OG002'}, {'value': '0.276', 'spread': '0.140', 'groupId': 'OG003'}, {'value': '0.216', 'spread': '0.119', 'groupId': 'OG004'}, {'value': '0.372', 'spread': '0.091', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.341', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'f statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.10', 'pValueComment': 'The threshold for statistical significance was 0.05.', 'groupDescription': 'It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.36', 'estimateComment': 'Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for PFST.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.27', 'ciUpperLimit': '0.38', 'estimateComment': 'Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for VSX.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.39', 'estimateComment': 'Additional model based estimates for 2-month estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'two months', 'description': 'Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Spectacles from the clinical treatment method were not dispensed to one participant in the Metric #1, then Clinical, then Metric #2 group due to failure of the safety criteria required for dispense. This spectacle prescription resulted in visual acuity worse than 7 letters from the participant's presenting acuity to the study."}, {'type': 'SECONDARY', 'title': 'Initial Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical, Then Metric #1, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG001', 'title': 'Clinical, Then Metric #2, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG002', 'title': 'Metric #1, Then Clinical, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG003', 'title': 'Metric #2, Then Clinical, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG004', 'title': 'Metric #1, Then Metric #2, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG005', 'title': 'Metric #2, Then Metric #1, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}], 'classes': [{'title': 'Treatment 1 Initial Dispense', 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '0.22', 'groupId': 'OG002'}, {'value': '0.28', 'spread': '0.13', 'groupId': 'OG003'}, {'value': '0.29', 'spread': '0.35', 'groupId': 'OG004'}, {'value': '0.33', 'spread': '0.09', 'groupId': 'OG005'}]}]}, {'title': 'Treatment 2 Initial Dispense', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '0.18', 'groupId': 'OG002'}, {'value': '0.30', 'spread': '0.22', 'groupId': 'OG003'}, {'value': '0.30', 'spread': '0.15', 'groupId': 'OG004'}, {'value': '0.34', 'spread': '0.07', 'groupId': 'OG005'}]}]}, {'title': 'Treatment 3 Initial Dispense', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '0.32', 'spread': '0.18', 'groupId': 'OG003'}, {'value': '0.28', 'spread': '0.14', 'groupId': 'OG004'}, {'value': '0.40', 'spread': '0.05', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.410', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'f statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.93', 'pValueComment': 'The threshold for statistical significance was 0.05.', 'groupDescription': 'It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.', 'statisticalMethod': 'f test', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.41', 'estimateComment': 'Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for PFST.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.26', 'ciUpperLimit': '0.39', 'estimateComment': 'Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for VSX.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.41', 'estimateComment': 'Additional model based estimates for initial visit estimated least square means in binocular visual acuity (logMAR) for Clinical Refraction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Spectacle Wear Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical, Then Metric #1, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG001', 'title': 'Clinical, Then Metric #2, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG002', 'title': 'Metric #1, Then Clinical, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG003', 'title': 'Metric #2, Then Clinical, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG004', 'title': 'Metric #1, Then Metric #2, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG005', 'title': 'Metric #2, Then Metric #1, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}], 'classes': [{'title': 'Period 2 Treatment 1 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '11.93', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '13.15', 'spread': '3.96', 'groupId': 'OG001'}, {'value': '10.48', 'spread': '4.08', 'groupId': 'OG002'}, {'value': '9.81', 'spread': '4.32', 'groupId': 'OG003'}, {'value': '8.40', 'spread': '4.29', 'groupId': 'OG004'}, {'value': '11.62', 'spread': '2.55', 'groupId': 'OG005'}]}]}, {'title': 'Period 3 Treatment 2 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9.50', 'spread': '5.50', 'groupId': 'OG000'}, {'value': '12.68', 'spread': '5.82', 'groupId': 'OG001'}, {'value': '12.31', 'spread': '4.74', 'groupId': 'OG002'}, {'value': '9.67', 'spread': '4.85', 'groupId': 'OG003'}, {'value': '9.26', 'spread': '4.17', 'groupId': 'OG004'}, {'value': '11.25', 'spread': '2.96', 'groupId': 'OG005'}]}]}, {'title': 'Period 4 Treatment 3 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '11.61', 'spread': '6.05', 'groupId': 'OG000'}, {'value': '13.32', 'spread': '4.53', 'groupId': 'OG001'}, {'value': '11.95', 'spread': '4.18', 'groupId': 'OG002'}, {'value': '9.47', 'spread': '5.12', 'groupId': 'OG003'}, {'value': '9.54', 'spread': '4.34', 'groupId': 'OG004'}, {'value': '11.31', 'spread': '3.06', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.351', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'f statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.09', 'pValueComment': 'The threshold for statistical significance was alpha=0.05.', 'groupDescription': 'It was calculated that 29 participants randomized in a 3x3 within-subject crossover design (repeated measures) achieves at least 89% power to detect an effect size of 0.25. Sample size was determined by a 2-sided f-test (alpha = 0.05) of the overall treatment effect based on a statistical simulation, simulating the repeated measures design. Assumptions included ICC of 0.3.', 'statisticalMethod': 'f test', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.0', 'ciLowerLimit': '9.3', 'ciUpperLimit': '12.7', 'estimateComment': 'Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for PFST.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.9', 'ciLowerLimit': '9.2', 'ciUpperLimit': '12.6', 'estimateComment': 'Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for VSX.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'least square means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.2', 'ciLowerLimit': '9.5', 'ciUpperLimit': '12.9', 'estimateComment': 'Additional model based estimates for two-month wear time estimated least square means in spectacle wear-time (Hours) for Clinical Refraction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'two months', 'description': 'Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For Period 3, one participant in group Metric #1, then Clinical, then Metric #2 did not receive the Clinical spectacle treatment because it failed the safety criteria for dispense. The clinical treatment for that participant reduced visual acuity greater than 7 letters from presenting acuity.'}, {'type': 'SECONDARY', 'title': 'Spectacle Assessment Survey Question 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical, Then Metric #1, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG001', 'title': 'Clinical, Then Metric #2, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG002', 'title': 'Metric #1, Then Clinical, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG003', 'title': 'Metric #2, Then Clinical, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG004', 'title': 'Metric #1, Then Metric #2, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG005', 'title': 'Metric #2, Then Metric #1, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}], 'classes': [{'title': 'Period 2 Treatment 1 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '5'}]}]}, {'title': 'Period 3 Treatment 2 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '4', 'upperLimit': '5'}]}]}, {'title': 'Period 4 Treatment 3 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '0.562', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'f statistic', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.58', 'groupDescription': "It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.967', 'estimateComment': 'Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for PFST.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.933', 'estimateComment': 'Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for VSX.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.897', 'estimateComment': 'Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 1 for Clinical Refraction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'two months', 'description': "Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'Do you like wearing this pair of glasses?' Responses were coded 1 through 5 with 5 = large smile.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense."}, {'type': 'SECONDARY', 'title': 'Spectacle Assessment Survey Question 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical, Then Metric #1, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG001', 'title': 'Clinical, Then Metric #2, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG002', 'title': 'Metric #1, Then Clinical, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG003', 'title': 'Metric #2, Then Clinical, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG004', 'title': 'Metric #1, Then Metric #2, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG005', 'title': 'Metric #2, Then Metric #1, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}], 'classes': [{'title': 'Period 2 Treatment 1 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '4', 'upperLimit': '5'}]}]}, {'title': 'Period 3 Treatment 2 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '4', 'upperLimit': '5'}]}]}, {'title': 'Period 4 Treatment 3 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '>0.99', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'groupDescription': "It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.967', 'estimateComment': 'Additional estimates of proportion of 2-month satisfactory responses (binary) for 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for PFST.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.967', 'estimateComment': 'Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for VSX.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.966', 'estimateComment': 'Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 2 for Clinical Refraction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'two months', 'description': "Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking far away?' Responses were coded 1 through 5 with 5 = large smile.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense."}, {'type': 'SECONDARY', 'title': 'Spectacle Assessment Survey Question 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical, Then Metric #1, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG001', 'title': 'Clinical, Then Metric #2, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG002', 'title': 'Metric #1, Then Clinical, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG003', 'title': 'Metric #2, Then Clinical, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG004', 'title': 'Metric #1, Then Metric #2, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'OG005', 'title': 'Metric #2, Then Metric #1, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}], 'classes': [{'title': 'Period 2 Treatment 1 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '5'}]}]}, {'title': 'Period 3 Treatment 2 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '4.5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '5', 'upperLimit': '5'}]}]}, {'title': 'Period 4 Treatment 3 Dispense to 2 Months Wear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG003', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG004', 'lowerLimit': '5', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG005', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '>0.99', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'groupDescription': "It was calculated that a sample size of n=28 yields 82% power to detect a difference of 0.4 in proportion of satisfaction (binary outcome of scores of '4' or '5' versus '1 to 3') in comparing two metrics using a two sided McNemar's test (alpha = 0.025 to account for pairwise testing).", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.967', 'estimateComment': 'Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for PFST.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.967', 'estimateComment': 'Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for VSX.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.966', 'estimateComment': 'Additional estimates of proportion of 2-month satisfactory responses (binary) for Spectacle Assessment Survey Item 3 for Clinical Refraction.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'two months', 'description': "Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking up close?' Responses were coded 1 through 5 with 5 = large smile.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "A single participant from group 'Metric #1, then Clinical, then Metric #2' was not dispensed the clinical treatment due to the treatment failing one of the safety criteria for dispense."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clinical, Then Metric #1, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'FG001', 'title': 'Clinical, Then Metric #2, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'FG002', 'title': 'Metric #1, Then Clinical, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'FG003', 'title': 'Metric #2, Then Clinical, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'FG004', 'title': 'Metric #1, Then Metric #2, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'FG005', 'title': 'Metric #2, Then Metric #1, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}], 'periods': [{'title': 'Initial Acuity at Dispense Visit (10min)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment 1 Dispense to 2 Months Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment 2 Dispense to 2 Months Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Treatment 3 Dispense to 2 Months Wear', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Clinical, Then Metric #1, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'BG001', 'title': 'Clinical, Then Metric #2, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'BG002', 'title': 'Metric #1, Then Clinical, Then Metric #2', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived, and lastly the metric-derived #2.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'BG003', 'title': 'Metric #2, Then Clinical, Then Metric #1', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived, and lastly the metric-derived #1.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'BG004', 'title': 'Metric #1, Then Metric #2, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'BG005', 'title': 'Metric #2, Then Metric #1, Then Clinical', 'description': "Subjects will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1, and lastly the clinically derived.\n\nSpectacles - Clinically Derived: Prescription spectacle lenses determined by clinically derived techniques of a masked examiner and may include autorefraction, retinoscopy, and subjective refraction obtained pre or post dilation.\n\nSpectacles - Metric Technique #1 Derived: For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX).\n\nSpectacles - Metric Technique #2 Derived: For this method, wavefront error will be measured with the COAS wavefront aberrometer post-dilation (3 - 5 captures per eye). Measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis is performed to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt)."}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '9', 'groupId': 'BG000'}, {'value': '30', 'spread': '13', 'groupId': 'BG001'}, {'value': '34', 'spread': '9', 'groupId': 'BG002'}, {'value': '28', 'spread': '12', 'groupId': 'BG003'}, {'value': '24', 'spread': '4', 'groupId': 'BG004'}, {'value': '28', 'spread': '10', 'groupId': 'BG005'}, {'value': '29', 'spread': '10', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Adaptive Behavior Standard Score', 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '99'}, {'value': '73', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '85'}, {'value': '59', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '78'}, {'value': '60', 'groupId': 'BG003', 'lowerLimit': '40', 'upperLimit': '79'}, {'value': '57', 'groupId': 'BG004', 'lowerLimit': '40', 'upperLimit': '71'}, {'value': '59', 'groupId': 'BG005', 'lowerLimit': '54', 'upperLimit': '81'}, {'value': '60', 'groupId': 'BG006', 'lowerLimit': '22', 'upperLimit': '99'}]}]}], 'paramType': 'MEDIAN', 'description': 'Participant developmental ability was assessed through the parent/guardian responses on the Vineland 2 Adaptive Assessment. Standard scores \\<70 indicate low adaptive functioning, scores from 70 to 85 indicate moderately low functioning, and scores from 86 to 115 indicate adequate adaptive function. The total range of possible standard scores on the Vineland is 20 to 160.', 'unitOfMeasure': 'Standard Score', 'dispersionType': 'FULL_RANGE'}, {'title': 'Binocular Distance Visual Acuity', 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '.10', 'groupId': 'BG000'}, {'value': '0.48', 'spread': '0.29', 'groupId': 'BG001'}, {'value': '0.40', 'spread': '0.13', 'groupId': 'BG002'}, {'value': '0.38', 'spread': '0.15', 'groupId': 'BG003'}, {'value': '0.46', 'spread': '0.16', 'groupId': 'BG004'}, {'value': '0.30', 'spread': '0.14', 'groupId': 'BG005'}, {'value': '0.39', 'spread': '0.17', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': "Visual Acuity with the participant's presenting correction (or unaided if that had no correction) was obtained with a computerized logMAR style chart with subjects identifying letters from 0.8 logMAR size to progressively smaller sizes in 0.1 logMAR steps (5 letters per line) until a total of 5 mistakes were made. Measures were performed with both eyes open rather than for each eye individually. The potential minimum score on the test (worst vision) was 0.90 logMAR and the potential maximum score (best vision) was -0.20 logMAR.", 'unitOfMeasure': 'logMAR', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number presenting with spectacles', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'This is the number of participants who were already wearing prescription spectacles at the time they entered the study.', 'unitOfMeasure': 'Participants'}, {'title': 'Refractive Error Classification', 'classes': [{'title': 'Myopia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}]}, {'title': 'Hyperopia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}]}, {'title': 'Mixed Astigmatism', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}]}, {'title': 'Emmetropia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Refractive error was classified for each eye based on the individual powers of the principal meridians and cylinder magnitude. Myopia was -0.50D or more myopia in both meridians. Hyperopia was a most plus meridian at least +1.00 D with the fellow meridian greater than or equal to 0 D. Mixed astigmatism was one principal meridian with plus power and the other with minus with at least 0.50 D cylinder. Emmetropia was both principal meridians between -0.50 and +1.00 D with less than 0.50 D cylinder.', 'unitOfMeasure': 'Number of Eyes'}, {'title': 'Autorefraction Spherical Equivalent OD', 'classes': [{'categories': [{'measurements': [{'value': '-1.68', 'spread': '4.53', 'groupId': 'BG000'}, {'value': '1.93', 'spread': '3.07', 'groupId': 'BG001'}, {'value': '-3.73', 'spread': '7.33', 'groupId': 'BG002'}, {'value': '0.98', 'spread': '1.27', 'groupId': 'BG003'}, {'value': '-1.75', 'spread': '4.37', 'groupId': 'BG004'}, {'value': '-5.23', 'spread': '4.75', 'groupId': 'BG005'}, {'value': '-1.58', 'spread': '4.88', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Unaided distance autorefraction was performed on the right eye. The spherical equivalent is reported as the spherical power plus 1/2 the cylindrical power.', 'unitOfMeasure': 'Diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Autorefraction Spherical Equivalent OS', 'classes': [{'categories': [{'measurements': [{'value': '-2.03', 'spread': '5.91', 'groupId': 'BG000'}, {'value': '1.95', 'spread': '2.52', 'groupId': 'BG001'}, {'value': '-2.68', 'spread': '6.81', 'groupId': 'BG002'}, {'value': '-0.05', 'spread': '2.43', 'groupId': 'BG003'}, {'value': '-1.58', 'spread': '4.55', 'groupId': 'BG004'}, {'value': '-3.53', 'spread': '3.73', 'groupId': 'BG005'}, {'value': '-1.32', 'spread': '4.59', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Unaided distance autorefraction was performed on the left eye. The spherical equivalent was calculated as the spherical power plus 1/2 the cylindrical power.', 'unitOfMeasure': 'Diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Autorefraction Cylinder OD', 'classes': [{'categories': [{'measurements': [{'value': '-1.45', 'spread': '0.67', 'groupId': 'BG000'}, {'value': '-3.65', 'spread': '1.43', 'groupId': 'BG001'}, {'value': '-2.65', 'spread': '2.91', 'groupId': 'BG002'}, {'value': '-2.25', 'spread': '1.08', 'groupId': 'BG003'}, {'value': '-1.50', 'spread': '0.68', 'groupId': 'BG004'}, {'value': '-1.35', 'spread': '0.68', 'groupId': 'BG005'}, {'value': '-2.14', 'spread': '1.58', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Unaided distance autorefraction was performed on the right eye. The cylindrical power is reported in minus cylinder form.', 'unitOfMeasure': 'Diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Autorefraction Cylinder OS', 'classes': [{'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.68', 'groupId': 'BG000'}, {'value': '-3.60', 'spread': '1.32', 'groupId': 'BG001'}, {'value': '-1.55', 'spread': '1.81', 'groupId': 'BG002'}, {'value': '-2.10', 'spread': '0.42', 'groupId': 'BG003'}, {'value': '-1.95', 'spread': '1.45', 'groupId': 'BG004'}, {'value': '-2.05', 'spread': '0.37', 'groupId': 'BG005'}, {'value': '-2.07', 'spread': '1.30', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'Unaided distance autorefraction was performed on the left eye. The cylindrical power is reported in minus cylinder form.', 'unitOfMeasure': 'Diopters', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Analysis was performed by participant. There was not a unit other than participants assigned to Arms/Groups.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-10-16', 'size': 322127, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-23T16:49', 'hasProtocol': True}, {'date': '2019-11-22', 'size': 130726, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-23T16:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'dispFirstSubmitDate': '2020-05-01', 'completionDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2017-12-05', 'dispFirstSubmitQcDate': '2021-09-27', 'resultsFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2017-12-05', 'dispFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-27', 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adapted Visual Acuity', 'timeFrame': 'two months', 'description': 'Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.'}], 'secondaryOutcomes': [{'measure': 'Initial Visual Acuity', 'timeFrame': '1 day', 'description': 'Aided LogMAR distance visual acuity obtained with either the British Standard Letters or HOTV - matching for subjects unable to name letters.'}, {'measure': 'Spectacle Wear Time', 'timeFrame': 'two months', 'description': 'Total wear time of each pair of spectacles as measured objectively by a temperature sensor data logger mounted to the spectacle temple.'}, {'measure': 'Spectacle Assessment Survey Question 1', 'timeFrame': 'two months', 'description': "Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'Do you like wearing this pair of glasses?' Responses were coded 1 through 5 with 5 = large smile."}, {'measure': 'Spectacle Assessment Survey Question 2', 'timeFrame': 'two months', 'description': "Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking far away?' Responses were coded 1 through 5 with 5 = large smile."}, {'measure': 'Spectacle Assessment Survey Question 3', 'timeFrame': 'two months', 'description': "Participants were asked to select a face from a survey with five expressions (large frown, small frown, neutral, small smile, large smile) depicting their response to the question 'How well do you see with this pair of glasses when looking up close?' Responses were coded 1 through 5 with 5 = large smile."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Vision, Low']}, 'referencesModule': {'references': [{'pmid': '34882603', 'type': 'DERIVED', 'citation': 'Anderson HA, Marsack JD, Benoit JS, Manny RE, Fern KD. Visual Acuity Outcomes in a Randomized Trial of Wavefront Metric-optimized Refractions in Adults with Down Syndrome. Optom Vis Sci. 2022 Jan 1;99(1):58-66. doi: 10.1097/OPX.0000000000001834.'}, {'pmid': '33394936', 'type': 'DERIVED', 'citation': 'Anderson HA, Benoit JS, Marsack JD, Manny RE, Ravikumar A, Fern KD, Trast KR. A Randomized Trial of Objective Spectacle Prescriptions for Adults with Down Syndrome: Baseline Data and Methods. Optom Vis Sci. 2021 Jan 1;98(1):88-99. doi: 10.1097/OPX.0000000000001631.'}]}, 'descriptionModule': {'briefSummary': 'This study tests the hypothesis that objectively derived spectacle prescriptions based on wavefront aberration measurements of the eyes of individuals with Down syndrome can provide an improvement in visual acuity over that obtained with spectacle prescriptions based on standard clinical prescribing techniques. The objectively derived prescriptions are derived using strategies to optimize retinal image quality as measured by image quality metrics, and thus these prescriptions will be referred to as metric-derived.', 'detailedDescription': 'Individuals with Down syndrome suffer from significant ocular complications including high levels of lower-order refractive error (sphere and cylinder) and elevated levels of higher-order aberrations. These optical factors likely contribute to the poor acuity observed in this population. Current clinical prescribing practices may under-serve this community, as the cognitive demands of the subjective refraction sequence are difficult for this population and often leave clinicians to prescribe from objective clinical findings that target full correction of sphero-cylindrical refractive error. This prescribing practice can lead to sub-par outcomes given the fact that full lower-order corrections can exacerbate the effects of higher-order aberrations in more aberrated eyes.\n\nFor this study, individuals with Down syndrome will be dispensed three pairs of spectacles for 2 months each, in random order: one clinically-derived, and two objectively-derived refractions based upon methods designed to optimize a given metric of retinal image quality which takes into consideration the wavefront aberration measurements of the eye. Both initial and adapted visual acuity in the presence of each correction will be evaluated to determine whether the objectively-derived refractions outperform clinically-derived refractions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Down syndrome\n\nExclusion Criteria:\n\n* Nystagmus (Involuntary beating movement of the eyes)\n* Visually significant media opacities (e.g. cataracts or corneal scars)\n* Strabismic amblyopia (reduced vision in one eye related to a constant eye-turn)\n* Anisometropic amblyopia (reduced vision in one eye related to a long-standing uncompensated difference in prescription between the two eyes)'}, 'identificationModule': {'nctId': 'NCT03367793', 'briefTitle': 'Spectacles for Patients With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Houston'}, 'officialTitle': 'Identification of Optimum Spectacle Prescriptions for Patients With Down Syndrome', 'orgStudyIdInfo': {'id': 'EY024590'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical, then Metric #1, then Metric #2', 'description': 'Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #1, and lastly the metric-derived #2.', 'interventionNames': ['Device: Spectacles - Clinically Derived', 'Device: Spectacles - Metric Technique #1 Derived', 'Device: Spectacles - Metric Technique #2 Derived']}, {'type': 'EXPERIMENTAL', 'label': 'Clinical, then Metric #2, then Metric #1', 'description': 'Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the clinically derived prescription first, followed by the metric-derived #2, and lastly the metric-derived #1.', 'interventionNames': ['Device: Spectacles - Clinically Derived', 'Device: Spectacles - Metric Technique #1 Derived', 'Device: Spectacles - Metric Technique #2 Derived']}, {'type': 'EXPERIMENTAL', 'label': 'Metric #1, then Clinical, then Metric #2', 'description': 'Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the clinically derived prescription, and lastly the metric-derived #2 prescription.', 'interventionNames': ['Device: Spectacles - Clinically Derived', 'Device: Spectacles - Metric Technique #1 Derived', 'Device: Spectacles - Metric Technique #2 Derived']}, {'type': 'EXPERIMENTAL', 'label': 'Metric #2, then Clinical, then Metric #1', 'description': 'Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the clinically derived prescription, and lastly the metric-derived #1 prescription.', 'interventionNames': ['Device: Spectacles - Clinically Derived', 'Device: Spectacles - Metric Technique #1 Derived', 'Device: Spectacles - Metric Technique #2 Derived']}, {'type': 'EXPERIMENTAL', 'label': 'Metric #1, then Metric #2, then Clinical', 'description': 'Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #1 prescription first, followed by the metric-derived #2 prescription, and lastly the clinically derived prescription.', 'interventionNames': ['Device: Spectacles - Clinically Derived', 'Device: Spectacles - Metric Technique #1 Derived', 'Device: Spectacles - Metric Technique #2 Derived']}, {'type': 'EXPERIMENTAL', 'label': 'Metric #2, then Metric #1, then Clinical', 'description': 'Each subject will receive all three spectacle prescription interventions dispensed in randomized order for 2 months of wear each. Subjects in this arm of the study will receive the metric-derived #2 prescription first, followed by the metric-derived #1 prescription, and lastly the clinically derived prescription.', 'interventionNames': ['Device: Spectacles - Clinically Derived', 'Device: Spectacles - Metric Technique #1 Derived', 'Device: Spectacles - Metric Technique #2 Derived']}], 'interventions': [{'name': 'Spectacles - Clinically Derived', 'type': 'DEVICE', 'otherNames': ['Glasses', 'Prescription Lenses', 'Spectacles'], 'description': 'Prescription spectacle lenses determined by clinically derived techniques. The specific techniques employed for each subject are left up to the masked examiner and are dependent upon the information needed for refraction determination, as well as ability of the participant to cooperate for testing. Measures may include autorefraction obtained pre or post dilation, retinoscopy obtained pre or post dilation, and subjective refraction obtained pre or post dilation.', 'armGroupLabels': ['Clinical, then Metric #1, then Metric #2', 'Clinical, then Metric #2, then Metric #1', 'Metric #1, then Clinical, then Metric #2', 'Metric #1, then Metric #2, then Clinical', 'Metric #2, then Clinical, then Metric #1', 'Metric #2, then Metric #1, then Clinical']}, {'name': 'Spectacles - Metric Technique #1 Derived', 'type': 'DEVICE', 'otherNames': ['Glasses', 'Prescription Lenses', 'Spectacles'], 'description': "Prescription spectacle lenses determined by metric-derived objective technique #1. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Visual Strehl ratio in the spatial domain (VSX). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #1 Derived.", 'armGroupLabels': ['Clinical, then Metric #1, then Metric #2', 'Clinical, then Metric #2, then Metric #1', 'Metric #1, then Clinical, then Metric #2', 'Metric #1, then Metric #2, then Clinical', 'Metric #2, then Clinical, then Metric #1', 'Metric #2, then Metric #1, then Clinical']}, {'name': 'Spectacles - Metric Technique #2 Derived', 'type': 'DEVICE', 'otherNames': ['Glasses', 'Prescription Lenses', 'Spectacles'], 'description': "Prescription spectacle lenses determined by metric-derived objective technique #2. For this method, wavefront error will be measured with the COAS (complete ophthalmic analysis system) wavefront aberrometer post-dilation with the goal of obtaining 3 to 5 high quality captures per eye. Wavefront measures will be re-sized to the patient's habitual pupil diameter and averaged. Post-measurement analysis will then be performed using a computer algorithm to identify the refractive correction predicted to produce the best image quality, as measured by maximization of the image quality metric Pupil Fraction tessellated (PFSt). The refractive correction determined from this analysis will be produced in prescription spectacle lenses and dispensed to the patient as the Intervention: Spectacles - Metric Technique #2 Derived.", 'armGroupLabels': ['Clinical, then Metric #1, then Metric #2', 'Clinical, then Metric #2, then Metric #1', 'Metric #1, then Clinical, then Metric #2', 'Metric #1, then Metric #2, then Clinical', 'Metric #2, then Clinical, then Metric #1', 'Metric #2, then Metric #1, then Clinical']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77204', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Heather A Anderson, OD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Heather A. Anderson', 'investigatorAffiliation': 'University of Houston'}}}}