Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-30 @ 5:52 PM
Study NCT ID:
NCT04936256
Status:
COMPLETED
Last Update Posted:
2024-08-07
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'claytonblehm@gmail.com', 'phone': '7705324444', 'title': 'Clayton Blehm, MD', 'organization': 'Gainesville Eye Associates'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 Months', 'eventGroups': [{'id': 'EG000', 'title': 'Bilateral Implantation of the Clareon Monofocal IOL', 'description': 'Clareon monofocal intraocular lens (IOL)\n\nClareon: Clareon monofocal intraocular lens (IOL)', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Refractive Stability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Clareon Monofocal IOL', 'description': 'Clareon monofocal intraocular lens (IOL)\n\nClareon: Clareon monofocal intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.028', 'upperLimit': '0.041'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months)', 'unitOfMeasure': 'Diopters (D)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binocular Uncorrected Distance Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Clareon Monofocal IOL', 'description': 'Clareon monofocal intraocular lens (IOL)\n\nClareon: Clareon monofocal intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Binocular uncorrected distance visual acuity in logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binocular Uncorrected Intermediate Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Clareon Monofocal IOL', 'description': 'Clareon monofocal intraocular lens (IOL)\n\nClareon: Clareon monofocal intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Binocular uncorrected intermediate visual acuity in logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binocular Corrected Distance Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Clareon Monofocal IOL', 'description': 'Clareon monofocal intraocular lens (IOL)\n\nClareon: Clareon monofocal intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Binocular corrected distance visual acuity in logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binocular Distance-corrected Intermediate Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Clareon Monofocal IOL', 'description': 'Clareon monofocal intraocular lens (IOL)\n\nClareon: Clareon monofocal intraocular lens (IOL)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.16', 'spread': '0.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Binocular distance-corrected intermediate visual acuity in logMAR', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Binocular Defocus Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bilateral Implantation of the Clareon Monofocal IOL', 'description': 'Clareon monofocal intraocular lens (IOL)\n\nClareon: Clareon monofocal intraocular lens (IOL)'}], 'classes': [{'title': '-4.0 D', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': '-3.5 D', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.14', 'groupId': 'OG000'}]}]}, {'title': '-3.0 D', 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': '-2.5 D', 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': '-2.0 D', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': '-1.5 D', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': '-1.0 D', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': '-0.5 D', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.11', 'groupId': 'OG000'}]}]}, {'title': '0.0 D', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.11', 'groupId': 'OG000'}]}]}, {'title': '0.5 D', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': '1.0 D', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'A binocular defocus curve is obtained by measuring visual acuity (logMAR) at different spherical powers (D).', 'unitOfMeasure': 'logMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bilateral Implantation of the Clareon Monofocal IOL', 'description': 'Clareon monofocal intraocular lens (IOL)\n\nClareon: Clareon monofocal intraocular lens (IOL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bilateral Implantation of the Clareon Monofocal IOL', 'description': 'Clareon monofocal intraocular lens (IOL)\n\nClareon: Clareon monofocal intraocular lens (IOL)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '72.1', 'spread': '5.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Only subjects who completed the study are included in the baseline analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-12', 'size': 338117, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-21T10:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2021-06-15', 'resultsFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-01', 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Refractive Stability', 'timeFrame': '3 months', 'description': 'Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months)'}], 'secondaryOutcomes': [{'measure': 'Binocular Uncorrected Distance Visual Acuity', 'timeFrame': '3 months', 'description': 'Binocular uncorrected distance visual acuity in logMAR'}, {'measure': 'Binocular Uncorrected Intermediate Visual Acuity', 'timeFrame': '3 months', 'description': 'Binocular uncorrected intermediate visual acuity in logMAR'}, {'measure': 'Binocular Corrected Distance Visual Acuity', 'timeFrame': '3 months', 'description': 'Binocular corrected distance visual acuity in logMAR'}, {'measure': 'Binocular Distance-corrected Intermediate Visual Acuity', 'timeFrame': '3 months', 'description': 'Binocular distance-corrected intermediate visual acuity in logMAR'}, {'measure': 'Binocular Defocus Curve', 'timeFrame': '3 months', 'description': 'A binocular defocus curve is obtained by measuring visual acuity (logMAR) at different spherical powers (D).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Monofocal IOL', 'Clareon'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The objective is to evaluate refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months).', 'detailedDescription': 'This study is a single-arm, evaluator masked clinical evaluation study of refractive stability, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and defocus curve.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects ≥50 years of age presenting for cataract surgery who are appropriate candidates for intraocular lens implantation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects are eligible for the study if they meet the following criteria:\n\nNote: Ocular criteria must be met in both eyes.\n\n* Presenting for uncomplicated bilateral cataract surgery and have an interest in an IOL option\n* Gender: Males and Females.\n* Age: 50 or older\n* Willing and able to provide written informed consent for participation in the study\n* Willing and able to comply with scheduled visits and other study procedures.\n* Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)\n* Potential postoperative visual acuity of (20/25 Snellen) or better in both eyes\n\nExclusion Criteria:\n\nIf any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.\n\n* Irregular astigmatism (e.g. keratoconus)\n* Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)\n* Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)\n* Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)\n* Diabetic retinopathy\n* Macular pathology (e.g. ARMD, ERM)\n* History of retinal detachment\n* Any patient based on Barrett toric calculator that will have ≥ 0.75D residual astigmatism if Clareon® non-toric IOL is implanted\n* Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity\n* Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating)\n\nThe principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.\n\nPregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.'}, 'identificationModule': {'nctId': 'NCT04936256', 'briefTitle': 'Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens', 'organization': {'class': 'OTHER', 'fullName': 'Gainesville Eye Associates'}, 'officialTitle': 'Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens', 'orgStudyIdInfo': {'id': 'CB-20-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bilateral implantation of the Clareon monofocal IOL', 'description': 'Clareon monofocal intraocular lens (IOL)', 'interventionNames': ['Device: Clareon']}], 'interventions': [{'name': 'Clareon', 'type': 'DEVICE', 'description': 'Clareon monofocal intraocular lens (IOL)', 'armGroupLabels': ['Bilateral implantation of the Clareon monofocal IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Gainesville Eye Associates', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}], 'overallOfficials': [{'name': 'Clayton Blehm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gainesville Eye Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gainesville Eye Associates', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sengi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}