Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-20 @ 9:38 PM
Study NCT ID:
NCT02965534
Status:
COMPLETED
Last Update Posted:
2019-02-28
First Post:
2016-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536122', 'term': 'Night blindness, congenital stationary'}]}, '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': 'philipp@hessler.de', 'phone': '+4916097089677', 'title': 'Philipp Hessler', 'organization': 'University of Applied Sciences Jena'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'study time', 'eventGroups': [{'id': 'EG000', 'title': 'Night Spectacle Correction', 'description': 'Refraction for this glasses was obtained at low luminance.\n\nSpectacle/Glasses', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Spectacle Correction for Photopic Light Conditions', 'description': 'Refraction for this glasses was obtained at high luminance level.\n\nSpectacle/Glasses', 'otherNumAtRisk': 100, 'deathsNumAtRisk': 100, 'otherNumAffected': 0, 'seriousNumAtRisk': 100, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Night Myopia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects'}], 'classes': [{'title': 'Right Eye (OD): shift in SE', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Left Eye (OS): shift in SE', 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline only', 'description': 'Value of refractive shift (SE) when changing luminance from a photopic to a mesopic level.\n\nAt Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group.', 'unitOfMeasure': 'D', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mesopic Visual Acuity Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects'}], 'classes': [{'title': 'Right Eye (OD): visual acuity improvement', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.4'}]}]}, {'title': 'Left Eye (OS): visual acuity improvement', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.3'}]}]}, {'title': 'Binocular visual acuity improvement', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline only', 'description': 'Difference of visual acuity (monocular and binocular) in a darkened room (0.1 lux) after a dark adaption period of 5 min. with photopic spectacle correction ("classic" refraction obtained in photopic light conditions) compared to mesopic spectacle correction (correction of night myopia)\n\nScale: logMAR visual acuity, using Landolt C optotypes.\n\nAt Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group.', 'unitOfMeasure': 'logMAR visual acuity', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Vision Comfort in Dark Light Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Night Spectacle Correction', 'description': 'Refraction for this glasses was obtained at low luminance.\n\nSpectacle/Glasses'}, {'id': 'OG001', 'title': 'Spectacle Correction for Photopic Light Conditions', 'description': 'Refraction for this glasses was obtained at high luminance level.\n\nSpectacle/Glasses'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': '31', 'groupId': 'OG000'}, {'value': '73', 'spread': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Test Period (4 weeks)', 'description': 'Evaluation of subjective perceived vision comfort with the study and control glasses.\n\nBoth glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.\n\nQuestion:\n\nHow would you evaluate vision comfort with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (insufficient) to 100 (very good)', 'unitOfMeasure': 'scores on a scale (0 to 100)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Vision Sharpness in Dark Light Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Night Spectacle Correction', 'description': 'Refraction for this glasses was obtained at low luminance.\n\nSpectacle/Glasses'}, {'id': 'OG001', 'title': 'Spectacle Correction for Photopic Light Conditions', 'description': 'Refraction for this glasses was obtained at high luminance level.\n\nSpectacle/Glasses'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '30', 'groupId': 'OG000'}, {'value': '73', 'spread': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Test Period (4 weeks)', 'description': 'Evaluation of subjective perceived vision sharpness with the study and control glasses.\n\nBoth glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.\n\nQuestion:\n\nHow would you evaluate vision sharpness with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (insufficient) to 100 (very good)', 'unitOfMeasure': 'evaluation points (0 to 100)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Glare Sensitivity in Dark Light Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Night Spectacle Correction', 'description': 'Refraction for this glasses was obtained at low luminance.\n\nSpectacle/Glasses'}, {'id': 'OG001', 'title': 'Spectacle Correction for Photopic Light Conditions', 'description': 'Refraction for this glasses was obtained at high luminance level.\n\nSpectacle/Glasses'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '32', 'groupId': 'OG000'}, {'value': '37', 'spread': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Test Period (4 weeks)', 'description': 'Evaluation of subjective perceived glare sensitivity with the study and control glasses.\n\nBoth glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.\n\nQuestion:\n\nHow would you evaluate glare sensitivity with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (no glare) to 100 (strong glare)', 'unitOfMeasure': 'scores on a scale (0 to 100)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Driving Safety in Dark Light Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Night Spectacle Correction', 'description': 'Refraction for this glasses was obtained at low luminance.\n\nSpectacle/Glasses'}, {'id': 'OG001', 'title': 'Spectacle Correction for Photopic Light Conditions', 'description': 'Refraction for this glasses was obtained at high luminance level.\n\nSpectacle/Glasses'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '32', 'groupId': 'OG000'}, {'value': '73', 'spread': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Test Period (4 weeks)', 'description': 'Evaluation of subjective perceived driving safety sense with the study and control glasses.\n\nBoth glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.\n\nQuestion:\n\nHow would you evaluate driving safety sense when driving in twilight or night with the tested glasses? Answer: visual analogue scale slider from 0 (not safe) to 100 (very safe)', 'unitOfMeasure': 'scores on a scale (0 to 100)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Night Spectacle Correction - Photopic Spectacle Correction', 'description': 'This arm has tested first the mesopic spectacle correction for 2 weeks and after this time the ("standard") photopic spectacle correction for two weeks\n\nCross Over Design!'}, {'id': 'FG001', 'title': 'Photopic Spectacle Correction - Night Spectacle Correction', 'description': 'This arm has tested first the standard photopic spectacle correction for two weeks and after this time the mesopic spectacle correction for two weeks\n\nCross Over Design!'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'test period: 14 days with each test glasses', 'groupId': 'FG000', 'numSubjects': '45'}, {'comment': 'test period: 14 days with each test glasses', 'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'All subjects were included in Baseline and all investigations were obtained at these 100 subjects'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Aberrometry Spherical Equivalent (SE) small pupil OD', 'classes': [{'categories': [{'measurements': [{'value': '-1.44', 'spread': '1.74', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'OD = right eye. Spherical Equivalent was calculated with data of an aberrometer (VISIONIX VX120 family).\n\nSpherical Equivalent is calculated by (sph + 0.5\\*cyl).', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aberrometry SE at small pupil OS', 'classes': [{'categories': [{'measurements': [{'value': '-1.36', 'spread': '1.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'SE = Spherical Equivalent. OS = left eye. Spherical Equivalent was calculated with data of an aberrometer (VISIONIX VX120 family).\n\nSpherical Equivalent is calculated by (sph + 0.5\\*cyl).', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subjective photopic Refraction SE OD', 'classes': [{'categories': [{'measurements': [{'value': '-1.10', 'spread': '1.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'SE = Spherical Equivalent OD = Right Eye\n\nSubjective Refraction measured in a photopic luminance level (comparable to an eye examination for new glasses). Spherical Equivalent was calculated with data of subjective refraction.\n\nSpherical Equivalent is calculated by (sph + 0.5\\*cyl).', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subjective photopic Refraction SE OS', 'classes': [{'categories': [{'measurements': [{'value': '-1.03', 'spread': '1.79', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'SE = Spherical Equivalent OS = Left Eye\n\nSubjective Refraction measured in a photopic luminance level (comparable to an eye examination for new glasses). Subjective Refraction measured in a photopic luminance level. Spherical Equivalent was calculated with data of subjective refraction.\n\nSpherical Equivalent is calculated by (sph + 0.5\\*cyl).', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Photopic Visual Acuity OD', 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'BG000', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEDIAN', 'description': 'Best Corrected Visual Acuity in a photopic luminance. OD = Right Eye\n\n0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32,\n\n-0.1 to 20/16, etc.', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'FULL_RANGE'}, {'title': 'Photopic Visual Acuity OS', 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'groupId': 'BG000', 'lowerLimit': '-0.2', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEDIAN', 'description': 'Best Corrected Visual Acuity in a photopic luminance OS = Left Eye. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32,\n\n-0.1 to 20/16, etc', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'FULL_RANGE'}, {'title': 'Binocular photopic Visual Acuity', 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'BG000', 'lowerLimit': '-0.3', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'description': 'Best Corrected Visual Acuity in a photopic luminance, binocular. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32,\n\n-0.1 to 20/16, etc.', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'FULL_RANGE'}, {'title': 'Mesopic Visual Acuity with photopic refraction OD', 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEDIAN', 'description': 'Visual Acuity measured in a mesopic luminance, wearing refraction values measured in photopic luminance OD = Right Eye. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32,\n\n-0.1 to 20/16, etc.', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'FULL_RANGE'}, {'title': 'Mesopic Visual Acuity with photopic refraction OS', 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'BG000', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEDIAN', 'description': 'Visual Acuity measured in a mesopic luminance, wearing refraction values measured in photopic luminance OS = Left Eye. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32,\n\n-0.1 to 20/16, etc.', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'FULL_RANGE'}, {'title': 'Mesopic Visual Acuity with photopic refraction Binocular', 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'BG000', 'lowerLimit': '-0.1', 'upperLimit': '0.3'}]}]}], 'paramType': 'MEDIAN', 'description': 'Visual Acuity measured in a mesopic luminance, wearing refraction values measured in photopic luminance Binocular.\n\n0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32,\n\n-0.1 to 20/16, etc.', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'FULL_RANGE'}, {'title': 'Subjective Mesopic Refraction SE OD', 'classes': [{'categories': [{'measurements': [{'value': '-1.42', 'spread': '1.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mesopic Refraction measured in mesopic luminance (comparable to an eye examination for new glasses in a darkened room).\n\nOD = Right Eye SE = Spherical Equivalent', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subjective Mesopic Refraction SE OS', 'classes': [{'categories': [{'measurements': [{'value': '-1.37', 'spread': '1.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Mesopic Refraction measured in mesopic luminance (comparable to an eye examination for new glasses in a darkened room).\n\nOS = Right Eye SE = Spherical Equivalent', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mesopic Visual Acuity with Mesopic Refraction OD', 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'BG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEDIAN', 'description': 'Best corrected visual acuity after refraction in mesopic luminance OD = Right Eye. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32,\n\n-0.1 to 20/16, etc.', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'FULL_RANGE'}, {'title': 'Mesopic Visual Acuity with Mesopic Refraction OS', 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'BG000', 'lowerLimit': '-0.1', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEDIAN', 'description': 'Best corrected visual acuity after refraction in mesopic luminance OS = Left Eye. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32,\n\n-0.1 to 20/16, etc.', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'FULL_RANGE'}, {'title': 'Mesopic Visual Acuity with Mesopic Refraction Binocular', 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'BG000', 'lowerLimit': '-0.2', 'upperLimit': '0.2'}]}]}], 'paramType': 'MEDIAN', 'description': 'Best corrected visual acuity after refraction in mesopic luminance Binocular. 0.0 corresponds to a Snellen Visual Acuity 20/20, 0.1 to 20/25, 0.2 to 20/32,\n\n-0.1 to 20/16, etc.', 'unitOfMeasure': 'logMAR Visual Acuity', 'dispersionType': 'FULL_RANGE'}, {'title': 'Spherical Aberration OD', 'classes': [{'categories': [{'measurements': [{'value': '0.100', 'spread': '0.15', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by Aberrometry OD = Right Eye', 'unitOfMeasure': 'µm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Spherical Aberration OS', 'classes': [{'categories': [{'measurements': [{'value': '0.093', 'spread': '0.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by Aberrometry OS = Left Eye', 'unitOfMeasure': 'µm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Max. pupil size aberrometry OD', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'measured by aberrometry OD = Right Eye', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Max. pupil size aberrometry OS', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '0.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'measured by aberrometry OS = Left Eye', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aberrometry Spherical Equivalent (SE) large pupil OD', 'classes': [{'categories': [{'measurements': [{'value': '-1.67', 'spread': '1.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'OD = Right Eye. Spherical Equivalent was calculated with data of an aberrometer (VISIONIX VX120 family).\n\nSpherical Equivalent is calculated by (sph + 0.5\\*cyl). SE value of max. pupil size.', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aberrometry Spherical Equivalent (SE) large pupil OS', 'classes': [{'categories': [{'measurements': [{'value': '-1.58', 'spread': '1.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'OS = Left Eye. Spherical Equivalent was calculated with data of an aberrometer (VISIONIX VX120 family).\n\nSpherical Equivalent is calculated by (sph + 0.5\\*cyl). SE value of max. pupil size.', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pupil size in photopic light conditions OD', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '1.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by Infra Red Camera in photopic conditions OD = Right Eye', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pupil size in photopic light conditions OS', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '1.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by Infra Red Camera in photooic conditions. OS = Left Eye', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pupil size in mesopic light conditions OD', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by Infra Red Camera in mesopic conditions. OD = Right Eye', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Pupil size in mesopic light conditions OS', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '1.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by Infra Red Camera in mesopic conditions OS = Left Eye', 'unitOfMeasure': 'mm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J0 Aberrometry OD small pupil', 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J0 = Astigmatism component OD = Right Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J0 Aberrometry OS small pupil', 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.29', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J0 = Astigmatism component OS = Left Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J45 Aberrometry OD small pupil', 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J45 = Astigmatism component OD = Right Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J45 Aberrometry OS small pupil', 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J45 = Astigmatism component OS = Left Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J0 Aberrometry OD large pupil', 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J0 = Astigmatism component OD = Right Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J0 Aberrometry OS large pupil', 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J0 = Astigmatism component OS = Left Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J45 Aberrometry OD large pupil', 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J45 = Astigmatism component OD = Right Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J45 Aberrometry OS large pupil', 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J45 = Astigmatism component OS = Left Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J0 Subjective Photopic Refraction OD', 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J0 = Astigmatism component Calculated after performing cross-cylinder method OD = Right Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J0 Subjective Photopic Refraction OS', 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J0 = Astigmatism component Calculated after performing cross-cylinder method OS = Left Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J45 Subjective Photopic Refraction OD', 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'spread': '0.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J45 = Astigmatism component Calculated after performing cross-cylinder method OD = Right Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J45 Subjective Photopic Refraction OS', 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J45 = Astigmatism component Calculated after performing cross-cylinder method OS = Left Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J0 Subjective Mesopic Refraction OD', 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J0 = Astigmatism component Calculated after performing cross-cylinder method in a darkened room OD = Right Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J0 Subjective Mesopic Refraction OS', 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J0 = Astigmatism component Calculated after performing cross-cylinder method in a darkened room OS = Left Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J45 Subjective Mesopic Refraction OD', 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J45 = Astigmatism component Calculated after performing cross-cylinder method in a darkened room OD = Right Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'J45 Subjective Mesopic Refraction OS', 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'J45 = Astigmatism component Calculated after performing cross-cylinder method in a darkened room OS = Left Eye', 'unitOfMeasure': 'D', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-16', 'studyFirstSubmitDate': '2016-11-14', 'resultsFirstSubmitDate': '2016-11-21', 'studyFirstSubmitQcDate': '2016-11-14', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-16', 'studyFirstPostDateStruct': {'date': '2016-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Night Myopia', 'timeFrame': 'Baseline only', 'description': 'Value of refractive shift (SE) when changing luminance from a photopic to a mesopic level.\n\nAt Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group.'}], 'secondaryOutcomes': [{'measure': 'Mesopic Visual Acuity Improvement', 'timeFrame': 'Baseline only', 'description': 'Difference of visual acuity (monocular and binocular) in a darkened room (0.1 lux) after a dark adaption period of 5 min. with photopic spectacle correction ("classic" refraction obtained in photopic light conditions) compared to mesopic spectacle correction (correction of night myopia)\n\nScale: logMAR visual acuity, using Landolt C optotypes.\n\nAt Baseline, participants were not separated into arms as the Randomization Process was carried out at a later time point after participants picked up study glasses. Therefore, data are presented for All Participants in one Arm/Group.'}, {'measure': 'Subjective Vision Comfort in Dark Light Conditions', 'timeFrame': 'Test Period (4 weeks)', 'description': 'Evaluation of subjective perceived vision comfort with the study and control glasses.\n\nBoth glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.\n\nQuestion:\n\nHow would you evaluate vision comfort with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (insufficient) to 100 (very good)'}, {'measure': 'Subjective Vision Sharpness in Dark Light Conditions', 'timeFrame': 'Test Period (4 weeks)', 'description': 'Evaluation of subjective perceived vision sharpness with the study and control glasses.\n\nBoth glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.\n\nQuestion:\n\nHow would you evaluate vision sharpness with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (insufficient) to 100 (very good)'}, {'measure': 'Subjective Glare Sensitivity in Dark Light Conditions', 'timeFrame': 'Test Period (4 weeks)', 'description': 'Evaluation of subjective perceived glare sensitivity with the study and control glasses.\n\nBoth glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.\n\nQuestion:\n\nHow would you evaluate glare sensitivity with the tested glasses in dark light conditions? Answer: visual analogue scale slider from 0 (no glare) to 100 (strong glare)'}, {'measure': 'Subjective Driving Safety in Dark Light Conditions', 'timeFrame': 'Test Period (4 weeks)', 'description': 'Evaluation of subjective perceived driving safety sense with the study and control glasses.\n\nBoth glasses (study and control glasses) were tested for two weeks each. After the two weeks test, each of the glasses was evaluated. For evaluation a visual analogue scale questionnaire (Scale 0 - 100) was used.\n\nQuestion:\n\nHow would you evaluate driving safety sense when driving in twilight or night with the tested glasses? Answer: visual analogue scale slider from 0 (not safe) to 100 (very safe)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['night vision', 'mesopic visual acuity', 'aberrometry', 'mesopic spectacle correction', 'night myopia'], 'conditions': ['Myopia-Night Blindness']}, 'descriptionModule': {'briefSummary': 'Reduced quality of vision and glare in twilight or night are frequently mentioned complaints within the optometric examination. A reason for these problems could be a myopic refractive shift in dark light conditions, commonly known as night myopia or twilight myopia.\n\nThe aim of this study was to investigate whether quality of vision in twilight or night could be improved by a spectacle correction optimized for mesopic light conditions. Moreover, objective refraction in large pupils measured by aberrometry was compared to subjective mesopic refraction.', 'detailedDescription': 'After obtaining informed consent, aberrometry was performed in a darkened room (0.1 lux). Subjective photopic refraction and visual acuity were measured before light was turned off and mesopic refraction was obtained after a dark adaptation period of five minutes. Finally, frames and lenses were fitted by a centration system. Lens grinding was executed centralized by a grinding workshop. In the course of this study, subjects were randomly assigned to wear two glasses double-masked in turn. One with photopic subjective refraction data and another with mesopic subjective refraction data. Both were worn for 14 ± 2 days each.\n\nFollow Up 1:\n\nAfter two weeks, participants were asked for their subjective experiences with the first correction by a visual analogue scale questionnaire. After the evaluation, glasses were changed.\n\nFollow Up 2:\n\nTwo weeks later, subjective experiences were evaluated again. After visual analogue scale questionnaire, subjects were asked to compare the two glasses concerning quality of mesopic vision and subjective safety level during night driving.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Visual Acuity at least 0.8 (5/6)\n* Binocular Vision\n\nExclusion Criteria:\n\n* refraction more than sph +/- 6 D and cyl 2 D\n* Difference between habitual correction and actual refraction more than 0.5 D\n* Medication with an influence on visual system\n* Disease or eye disease with an effect on the visual system\n* pregnancy or other hormonal variances\n* influence of drugs\n* mental handicap'}, 'identificationModule': {'nctId': 'NCT02965534', 'briefTitle': 'Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality', 'organization': {'class': 'OTHER', 'fullName': 'University of Applied Sciences Jena'}, 'officialTitle': 'Evaluation of a Night Spectacle Correction Concerning an Improvement of Mesopic Vision Quality', 'orgStudyIdInfo': {'id': 'IGAMYO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Night Spectacle Correction', 'description': 'Refraction for this glasses was obtained at low luminance.', 'interventionNames': ['Device: Spectacle/Glasses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spectacle Correction for photopic light conditions', 'description': 'Refraction for this glasses was obtained at high luminance level.', 'interventionNames': ['Device: Spectacle/Glasses']}], 'interventions': [{'name': 'Spectacle/Glasses', 'type': 'DEVICE', 'armGroupLabels': ['Night Spectacle Correction', 'Spectacle Correction for photopic light conditions']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Augsburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Degle Optometry', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '63911', 'city': 'Klingenberg am Main', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Hessler Optometry', 'geoPoint': {'lat': 49.78507, 'lon': 9.18025}}, {'zip': '07745', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'University of Applied Sciences', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Stephan Degle, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Applied Sciences Jena'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Applied Sciences Jena', 'class': 'OTHER'}, 'collaborators': [{'name': 'IGA OPTIC EG', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Stephan Degle', 'investigatorAffiliation': 'University of Applied Sciences Jena'}}}}