Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-04-14 @ 2:39 PM
Study NCT ID:
NCT02821403
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2016-06-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Blue-light Blocking Lens on Visual Functions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeffrey.TW.leung@polyu.edu.hk', 'phone': '27664268', 'title': 'Dr. Tsz Wing Leung', 'organization': 'The Hong Kong Polytechnic University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'There was no foreseeable safety issue and adverse effect. Serious and Other \\[Not Including Serious\\] Adverse Events were not collected/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Young Adults', 'description': 'adults without presbyopia who aged 18-35 years\n\nThree spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Middle-aged Adults', 'description': 'adults with presbyopia who aged over 40 years\n\nThree spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults: Clear Lens With Regular Coating', 'description': 'adults without presbyopia who aged 18-35 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'OG001', 'title': 'Young Adults: Regular Coating Lens With Yellow Tint', 'description': 'adults without presbyopia who aged 18-35 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'OG002', 'title': 'Young Adults: Clear Lens With Blue-light Blocking Coating', 'description': 'adults without presbyopia who aged 18-35 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'OG003', 'title': 'Middle-aged Adults: Clear Lens With Regular Coating', 'description': 'adults with presbyopia who aged over 40 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'OG004', 'title': 'Middle-aged Adults: Regular Coating Lens With Yellow Tint', 'description': 'adults with presbyopia who aged over 40 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'OG005', 'title': 'Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin', 'description': 'adults with presbyopia who aged over 40 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}], 'classes': [{'title': 'without glare', 'categories': [{'measurements': [{'value': '1.866', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '1.861', 'spread': '0.005', 'groupId': 'OG001'}, {'value': '1.856', 'spread': '0.008', 'groupId': 'OG002'}, {'value': '1.818', 'spread': '0.014', 'groupId': 'OG003'}, {'value': '1.799', 'spread': '0.016', 'groupId': 'OG004'}, {'value': '1.802', 'spread': '0.013', 'groupId': 'OG005'}]}]}, {'title': 'with glare', 'categories': [{'measurements': [{'value': '1.817', 'spread': '0.015', 'groupId': 'OG000'}, {'value': '1.802', 'spread': '0.032', 'groupId': 'OG001'}, {'value': '1.777', 'spread': '0.035', 'groupId': 'OG002'}, {'value': '1.759', 'spread': '0.019', 'groupId': 'OG003'}, {'value': '1.768', 'spread': '0.018', 'groupId': 'OG004'}, {'value': '1.785', 'spread': '0.017', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every 1-month interval from the date of randomization, up to 3 months', 'description': 'Contrast sensitivity was measured using the Mars contrast sensitivity letter chart (Mars Perceptrix, Chappaqua, NY). One out of three charts differing in the letter combinations was selected randomly in order to avoid memorization of the charts. The chart was placed at 50 cm with each letter subtended 2° visual angle. We followed the recording procedures as specified by the manufacturer: participants were instructed to read the letters from high to low contrasts and the test ended when two consecutive errors were made. The contrast sensitivity was scored as the log contrast sensitivity of the last correct letter minus 0.04 log unit for every prior error. The test was administered under normal (room illumination, 400 lux) and glare conditions. A brightness acuity tester set at its medium light intensity level (100 foot lamberts) simulated the glaring condition.\n\nA higher mean indicates improved contrast sensitivity.', 'unitOfMeasure': 'log contrast sensitivity score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Color Vision as Assessed by the Farnsworth Munsell 100 Hue Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults: Clear Lens With Regular Coating', 'description': 'adults without presbyopia who aged 18-35 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'OG001', 'title': 'Young Adults: Regular Coating Lens With Yellow Tint', 'description': 'adults without presbyopia who aged 18-35 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'OG002', 'title': 'Young Adults: Clear Lens With Blue-light Blocking Coating', 'description': 'adults without presbyopia who aged 18-35 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'OG003', 'title': 'Middle-aged Adults: Clear Lens With Regular Coating', 'description': 'adults with presbyopia who aged over 40 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'OG004', 'title': 'Middle-aged Adults: Regular Coating Lens With Yellow Tint', 'description': 'adults with presbyopia who aged over 40 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'OG005', 'title': 'Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin', 'description': 'adults with presbyopia who aged over 40 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nThe sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'spread': '3.34', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '3.36', 'groupId': 'OG001'}, {'value': '30.1', 'spread': '3.00', 'groupId': 'OG002'}, {'value': '49.1', 'spread': '5.49', 'groupId': 'OG003'}, {'value': '54.65', 'spread': '4.66', 'groupId': 'OG004'}, {'value': '52.4', 'spread': '5.21', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every 1-month interval from the date of randomization, up to 3 months', 'description': 'The Farnsworth Munsell 100 hue test (X-Rite, USA) was used to evaluate colour vision. Each of the four trays consisted of 21 movable caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score was calculated, as documented in the instruction manual, to quantify the accuracy of color discrimination.\n\nThere are no defined endpoints to the "total error score" range.\n\nA lower score indicates improved color discrimination ability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-assessment of Lens Performance Through Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Young Adults', 'description': 'adults without presbyopia who aged 18-35 years\n\nThree spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating'}, {'id': 'OG001', 'title': 'Middle-aged Adults', 'description': 'adults with presbyopia who aged over 40 years\n\nThree spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating'}], 'classes': [{'title': 'clear lens with regular coating', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'regular coating lens with yellow tint', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'clear lens with blue-light blocking coating', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Every 1-month interval from the date of randomization, up to 3 months', 'description': 'After each monthly wearing period (visits 3-5), the participants\' lens performance, night vision quality and sleep quality (total 13 questions) were assessed subjectively using a questionnaire (scoring from 1 \\[very unsatisfactory\\] to 5 \\[very satisfactory\\]).\n\nAt the end of the study, the participants were asked to choose their preferred lens type among the three pairs of lenses based on their subjective feeling of the "best lens type" (i.e., either clear lens, yellow tinted lens or blue-filtering coated lens).\n\nTo make it clear and simple, here we only present the data on the participants choice of their preferred lens type (i.e., simply choosing the "best lens" among clear lens, yellow tinted lens or blue-filtering coated lens).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Young Adults', 'description': 'adults without presbyopia who aged 18-35 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nCross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}, {'id': 'FG001', 'title': 'Middle-aged Adults', 'description': 'adults with presbyopia who aged over 40 years\n\nThree types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.\n\nCross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission.'}], 'periods': [{'title': '"First Intervention (1 Month)"', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Used Clear Lens', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Used Yellow Tinted Lens', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Used Blue-filtering Coated Lens', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '"Second Intervention (1 Month)"', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Used Clear Lens', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Used Yellow Tinted Lens', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Used Blue-filtering Coated Lens', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '"Third Intervention (1 Month)"', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Used Clear Lens', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Used Yellow Tinted Lens', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Used Blue-filtering Coated Lens', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Young Adults', 'description': 'adults without presbyopia who aged 18-35 years\n\nThree spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating'}, {'id': 'BG001', 'title': 'Middle-aged Adults', 'description': 'adults with presbyopia who aged over 40 years\n\nThree spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2016-06-27', 'resultsFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-23', 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast Sensitivity as Assessed by Mars Contrast Sensitivity Chart', 'timeFrame': 'Every 1-month interval from the date of randomization, up to 3 months', 'description': 'Contrast sensitivity was measured using the Mars contrast sensitivity letter chart (Mars Perceptrix, Chappaqua, NY). One out of three charts differing in the letter combinations was selected randomly in order to avoid memorization of the charts. The chart was placed at 50 cm with each letter subtended 2° visual angle. We followed the recording procedures as specified by the manufacturer: participants were instructed to read the letters from high to low contrasts and the test ended when two consecutive errors were made. The contrast sensitivity was scored as the log contrast sensitivity of the last correct letter minus 0.04 log unit for every prior error. The test was administered under normal (room illumination, 400 lux) and glare conditions. A brightness acuity tester set at its medium light intensity level (100 foot lamberts) simulated the glaring condition.\n\nA higher mean indicates improved contrast sensitivity.'}, {'measure': 'Color Vision as Assessed by the Farnsworth Munsell 100 Hue Test', 'timeFrame': 'Every 1-month interval from the date of randomization, up to 3 months', 'description': 'The Farnsworth Munsell 100 hue test (X-Rite, USA) was used to evaluate colour vision. Each of the four trays consisted of 21 movable caps. Participants were asked to sort the randomly arranged caps following the hue order from the first to the last fixed caps. The total error score was calculated, as documented in the instruction manual, to quantify the accuracy of color discrimination.\n\nThere are no defined endpoints to the "total error score" range.\n\nA lower score indicates improved color discrimination ability.'}], 'secondaryOutcomes': [{'measure': 'Self-assessment of Lens Performance Through Questionnaire', 'timeFrame': 'Every 1-month interval from the date of randomization, up to 3 months', 'description': 'After each monthly wearing period (visits 3-5), the participants\' lens performance, night vision quality and sleep quality (total 13 questions) were assessed subjectively using a questionnaire (scoring from 1 \\[very unsatisfactory\\] to 5 \\[very satisfactory\\]).\n\nAt the end of the study, the participants were asked to choose their preferred lens type among the three pairs of lenses based on their subjective feeling of the "best lens type" (i.e., either clear lens, yellow tinted lens or blue-filtering coated lens).\n\nTo make it clear and simple, here we only present the data on the participants choice of their preferred lens type (i.e., simply choosing the "best lens" among clear lens, yellow tinted lens or blue-filtering coated lens).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Effects of Blue-light Blocking Lens on Visual Functions']}, 'referencesModule': {'references': [{'pmid': '16950247', 'type': 'BACKGROUND', 'citation': 'Wu J, Seregard S, Algvere PV. Photochemical damage of the retina. Surv Ophthalmol. 2006 Sep-Oct;51(5):461-81. doi: 10.1016/j.survophthal.2006.06.009.'}, {'pmid': '2095019', 'type': 'BACKGROUND', 'citation': 'Taylor HR, Munoz B, West S, Bressler NM, Bressler SB, Rosenthal FS. Visible light and risk of age-related macular degeneration. Trans Am Ophthalmol Soc. 1990;88:163-73; discussion 173-8.'}, {'pmid': '815821', 'type': 'BACKGROUND', 'citation': 'Ham WT Jr, Mueller HA, Sliney DH. Retinal sensitivity to damage from short wavelength light. Nature. 1976 Mar 11;260(5547):153-5. doi: 10.1038/260153a0. No abstract available.'}, {'pmid': '14172613', 'type': 'BACKGROUND', 'citation': 'WALD G. THE RECEPTORS OF HUMAN COLOR VISION. Science. 1964 Sep 4;145(3636):1007-16. doi: 10.1126/science.145.3636.1007. No abstract available.'}, {'pmid': '7499092', 'type': 'BACKGROUND', 'citation': 'Aggarwala KR, Nowbotsing S, Kruger PB. Accommodation to monochromatic and white-light targets. Invest Ophthalmol Vis Sci. 1995 Dec;36(13):2695-705.'}, {'pmid': '8594811', 'type': 'BACKGROUND', 'citation': 'Kruger PB, Mathews S, Aggarwala KR, Yager D, Kruger ES. Accommodation responds to changing contrast of long, middle and short spectral-waveband components of the retinal image. Vision Res. 1995 Sep;35(17):2415-29. doi: 10.1016/0042-6989(94)00316-5.'}, {'pmid': '19547745', 'type': 'BACKGROUND', 'citation': 'Dijk DJ, Archer SN. Light, sleep, and circadian rhythms: together again. PLoS Biol. 2009 Jun 16;7(6):e1000145. doi: 10.1371/journal.pbio.1000145. Epub 2009 Jun 23. No abstract available.'}, {'pmid': '12970330', 'type': 'BACKGROUND', 'citation': 'Lockley SW, Brainard GC, Czeisler CA. High sensitivity of the human circadian melatonin rhythm to resetting by short wavelength light. J Clin Endocrinol Metab. 2003 Sep;88(9):4502-5. doi: 10.1210/jc.2003-030570.'}, {'pmid': '28045969', 'type': 'DERIVED', 'citation': 'Leung TW, Li RW, Kee CS. Blue-Light Filtering Spectacle Lenses: Optical and Clinical Performances. PLoS One. 2017 Jan 3;12(1):e0169114. doi: 10.1371/journal.pone.0169114. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Working Hypothesis: The blue-light blocking lens has no effect on the contrast sensitivity, accommodative response, color vision, and subjective grading of the quality of life and vision.\n\nPurpose: To determine and compare the visual performances after wearing the blue-light blocking lenses in participants with and without presbyopia.\n\nMethods: One hundred and sixty computer users (computer usage \\>2 hours/day) with (n=120, aged \\>40years) and without presbyopia (n=40, aged 18-35 years) will be recruited. Three pairs of ophthalmic lenses will be prescribed for the participants, in which one pair of them will be the blue-light blocking lenses (StressFree, Swisscoat, HK). The lenses will be used for intermediate vision (i.e., computer usage) in presbyopic group, and for distant vision in non-presbyopic group. The adaptation period for each pair of lenses will be 1 month. The pre- and post-treatment contrast sensitivity, accommodative response and color vision will be measured. The participants will also be asked to complete questionnaires about their quality of life and vision, and the performances of these ophthalmic lenses.\n\nSignificance: The blue-light blocking lens reflects the short-wavelength lights and protects the retina from "blue-light hazards"; however, blue lights are essential for various visual function and circadian rhythms. This study will evaluate the impact of the blue-light blocking lenses on visual function and quality of life, and determine whether the blue-light blocking lenses are good choices for extra ocular protection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18 to 35 years OR 40 to 55 years\n* daily computer usage over over 2 hours per day\n\nExclusion Criteria:\n\n* visual acuity worst than 0 logMAR\n* abnormal binocular and color vision\n* previous history of ocular surgeries'}, 'identificationModule': {'nctId': 'NCT02821403', 'briefTitle': 'Effects of Blue-light Blocking Lens on Visual Functions', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'orgStudyIdInfo': {'id': 'HSEARS20140512001-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Young adults', 'description': 'adults without presbyopia who aged 18-35 years', 'interventionNames': ['Device: clear lens with regular coating', 'Device: regular coating lens with yellow tint', 'Device: clear lens with blue-light blocking coating']}, {'type': 'EXPERIMENTAL', 'label': 'Middle-aged adults', 'description': 'adults with presbyopia who aged over 40 years', 'interventionNames': ['Device: clear lens with regular coating', 'Device: regular coating lens with yellow tint', 'Device: clear lens with blue-light blocking coating']}], 'interventions': [{'name': 'clear lens with regular coating', 'type': 'DEVICE', 'armGroupLabels': ['Middle-aged adults', 'Young adults']}, {'name': 'regular coating lens with yellow tint', 'type': 'DEVICE', 'armGroupLabels': ['Middle-aged adults', 'Young adults']}, {'name': 'clear lens with blue-light blocking coating', 'type': 'DEVICE', 'armGroupLabels': ['Middle-aged adults', 'Young adults']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}