Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT00315302
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2006-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000550', 'term': 'Amblyopia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pedig@jaeb.org', 'phone': '813-975-8690', 'title': 'Raymond Kraker', 'organization': 'Jaeb Center for Health Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected through the 18wk outcome visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)', 'otherNumAtRisk': 90, 'otherNumAffected': 8, 'seriousNumAtRisk': 90, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)', 'otherNumAtRisk': 90, 'otherNumAffected': 1, 'seriousNumAtRisk': 90, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)', 'otherNumAtRisk': 26, 'otherNumAffected': 1, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)', 'otherNumAtRisk': 34, 'otherNumAffected': 5, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Light sensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Acuity Mean Score in the Amblyopic Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'OG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '0.54', 'spread': '0.26', 'groupId': 'OG002'}, {'value': '0.50', 'spread': '0.38', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.24', 'estimateComment': 'The difference was calculated as atropine plus plano group minus atropine group', 'groupDescription': 'The primary analysis was a treatment group comparison of logMAR visual acuity scores in the amblyopic eye obtained 18 weeks after randomization, adjusted for baseline acuity scores in an analysis of covariance (ANCOVA) model.\n\nThe primary analysis included only patients with visual acuity of 20/40 to 20/100; sample size was based upon a two-sided alpha of 0.05, with 90% power to detect a difference if the true difference in change from baseline between groups was 0.075 logMAR at 18 weeks.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '18 weeks', 'description': 'Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.\n\n20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst', 'unitOfMeasure': 'logMAR units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analysis includes only patients who completed the 18 week exam. No imputation was done if missed exam; analysis followed the intent to treat principle.'}, {'type': 'PRIMARY', 'title': 'Visual Acuity Distribution in the Amblyopic Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'OG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}], 'classes': [{'title': '20/400 (worse)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '20/320', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '20/250', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '20/200', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '20/160', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '20/125', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '20/100', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '20/80', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '20/63', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '20/50', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '20/40', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '20/32', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': '20/25', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '20/20', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '20/16 (better)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: proportion 20/25 or better at 18wks in atropine group = proportion 20/25 or better at 18wks in atropine plus plano group\n\nAlternative hypothesis: proportion 20/25 or better at 18wks in atropine group NOT equal to proportion 20/25 or better at 18wks in atropine plus plano group', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'proportion 20/25 as a function of treatment group controlling for baseline acuity', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 weeks', 'description': 'Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.\n\n20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Change in Visual Acuity in the Amblyopic Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'OG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '3.1', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '3.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '3.2', 'ciUpperLimit': '5.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.1', 'groupDescription': '95% confidence interval calculated within treatment group on the amount of change from baseline', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '3.7', 'ciUpperLimit': '6.4', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.7', 'groupDescription': '95% confidence interval calculated within treatment group on the amount of change from baseline', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 18 weeks', 'description': 'Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.\n\nA positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.', 'unitOfMeasure': 'logMAR units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Distribution of Change in Visual Acuity in the Amblyopic Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'OG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}], 'classes': [{'title': '-3 (worse)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '-2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '-1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '0', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '+1', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '+2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '+3', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '+4', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '>= +5 (better)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: proportion 3 or more lines better at 18wks in atropine group = proportion 3 or more lines better at 18wks in atropine plus plano group\n\nAlternative hypothesis: proportion 3 or more lines better at 18wks in atropine group NOT equal to proportion 3 or more lines better at 18wks in atropine plus plano group', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'proportion 20/25 as a function of treatment group controlling for baseline acuity', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to 18 weeks', 'description': 'Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.\n\nA positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'OG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}], 'classes': [{'title': 'Failed black & white shape identification pretest', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '>800 arcsec (worst)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': '800 arcsec', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '400 arcsec', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '200 arcsec', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '100 arcsec', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': '60 arcsec', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '40 arcsec (best)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Not done', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'All patients without respect to cause of amblyopia.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 weeks', 'description': 'The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \\>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not reported among subjects with severe amblyopia'}, {'type': 'SECONDARY', 'title': 'Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'OG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}], 'classes': [{'title': 'Failed black & white shape identification pretest', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '>800 arcsec (worst)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '800 arcsec', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '400 arcsec', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '200 arcsec', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '100 arcsec', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '60 arcsec', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '40 arcsec (best)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Not done', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Among anisometropic patients only', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Wilcoxon rank sum test to evaluate difference in change from baseline in stereoacuity by treatment group', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '18 weeks', 'description': 'The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \\>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not reported among subjects with severe amblyopia'}, {'type': 'SECONDARY', 'title': 'Mean Change in Visual Acuity in the Sound Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'OG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '0.15', 'spread': '0.15', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 18 weeks', 'description': 'Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.\n\nA positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.', 'unitOfMeasure': 'logMAR units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distribution of Change in Visual Acuity in the Sound Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'OG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}], 'classes': [{'title': '-4 (worse)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '-3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '-2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '-1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '0', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': '+1', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': '+2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '+3 (better)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups;\n\nAlternate: proportion 1 or more lines worse and worse than 20/20 at 18wks same in both groups', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to 18 weeks', 'description': 'Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.\n\nA positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Acuity Distribution in the Sound Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'OG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'OG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}], 'classes': [{'title': '20/63 (worse)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '20/50', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '20/40', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '20/32', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': '20/25', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': '20/20', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': '20/16 (better)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '18 weeks', 'description': 'Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18 wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.\n\n20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'FG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'FG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'FG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': '5 Week Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': '10 Week Visit', 'achievements': [{'comment': 'Can be higher as includes subjects who may have missed the 5 week visit', 'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': '18 Week Primary Outcome Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'comment': 'Can be higher as includes subjects who may have missed the 10 week or other visit', 'groupId': 'FG001', 'numSubjects': '88'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'comment': 'Can be higher as includes subjects who may have missed the 10 week or other visit', 'groupId': 'FG003', 'numSubjects': '31'}]}, {'type': 'Partial Responder Phase (Post 18 Weeks)', 'achievements': [{'comment': 'Those who improved in the amblyopic eye at 18wk outcome continued on treatment w/ visits every 8wks.', 'groupId': 'FG000', 'numSubjects': '16'}, {'comment': 'Those who improved in the amblyopic eye at 18wk outcome continued on treatment w/ visits every 8wks.', 'groupId': 'FG001', 'numSubjects': '13'}, {'comment': 'Those who improved in the amblyopic eye at 18wk outcome continued on treatment w/ visits every 8wks.', 'groupId': 'FG002', 'numSubjects': '9'}, {'comment': 'Those who improved in the amblyopic eye at 18wk outcome continued on treatment w/ visits every 8wks.', 'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed defined as completing 18 week primary outcome exam', 'groupId': 'FG000', 'numSubjects': '84'}, {'comment': 'Completed defined as completing 18 week primary outcome exam', 'groupId': 'FG001', 'numSubjects': '88'}, {'comment': 'Completed defined as completing 18 week primary outcome exam', 'groupId': 'FG002', 'numSubjects': '24'}, {'comment': 'Completed defined as completing 18 week primary outcome exam', 'groupId': 'FG003', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Between Feb 2005 and May 2007, 240 subjects were randomized at 30 sites (180 with moderate amblyopia 20/40 to 20/100 in a primary cohort, and an additional 60 with severe amblyopia 20/125 to 20/400 that were followed as a secondary cohort).', 'preAssignmentDetails': 'Subjects must have had stable visual acuity in glasses (if applicable) before enrollment and randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '240', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Atropine-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'BG001', 'title': 'Atropine Plus Plano-Moderate Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)'}, {'id': 'BG002', 'title': 'Atropine-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)'}, {'id': 'BG003', 'title': 'Atropine Plus Plano-Severe Amblyopia', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '240', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Age at enrollment', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '4.5', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '4.4', 'spread': '1.0', 'groupId': 'BG003'}, {'value': '5.0', 'spread': '1.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Age at enrollment', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '196', 'groupId': 'BG004'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Unknown / Not reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '239', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Cause of Amblyopia', 'classes': [{'title': 'Strabismus', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '96', 'groupId': 'BG004'}]}]}, {'title': 'Anisometropia', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}, {'title': 'Strabismus and anisometropia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Distance Visual Acuity in Amblyopic Eye', 'classes': [{'title': '20/400 (worse)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': '20/320', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': '20/250', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': '20/200', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': '20/160', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': '20/125', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}, {'title': '20/100', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}, {'title': '20/80', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '29', 'groupId': 'BG004'}]}]}, {'title': '20/63', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}]}]}, {'title': '20/50', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}, {'title': '20/40 (better)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.\n\n20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst', 'unitOfMeasure': 'participants'}, {'title': 'Distance Visual Acuity in Sound Eye', 'classes': [{'title': '20/40 (worse)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': '20/32', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}]}]}, {'title': '20/25', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}]}, {'title': '20/20', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '75', 'groupId': 'BG004'}]}]}, {'title': '20/16 (better)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.\n\n20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst', 'unitOfMeasure': 'participants'}, {'title': 'Prior Treatment for Amblyopia at Enrollment', 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '200', 'groupId': 'BG004'}]}]}, {'title': 'Patching', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}, {'title': 'Atropine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Patching and Atropine', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Refractive Error in Amblyopic Eye (spherical equivalent/diopters)', 'classes': [{'title': '0 to < +1.00 D', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': '+1.00 to < +2.00 D', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': '+2.00 D to < +3.00 D', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': '+3.00 D to < +4.00 D', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}]}]}, {'title': '>= +4.00 D', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '180', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Spherical equivalent is defined as the sphere plus 1/2 the cylinder.', 'unitOfMeasure': 'participants'}, {'title': 'Refractive Error in Sound Eye (spherical equivalent/diopters)', 'classes': [{'title': '+ 1.50 to < + 2.00 D', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}, {'title': '+ 2.00 D to < + 3.00 D', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}, {'title': '+3.00 D to < + 4.00 D', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}, {'title': '>= + 4.00 D', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Spherical equivalent is defined as the sphere plus 1/2 the cylinder.', 'unitOfMeasure': 'participants'}, {'title': 'Distance Visual Acuity in Amblyopic Eye', 'classes': [{'categories': [{'measurements': [{'value': '0.47', 'spread': '0.12', 'groupId': 'BG000'}, {'value': '0.50', 'spread': '0.13', 'groupId': 'BG001'}, {'value': '0.99', 'spread': '0.16', 'groupId': 'BG002'}, {'value': '1.01', 'spread': '0.20', 'groupId': 'BG003'}, {'value': '0.61', 'spread': '0.27', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.\n\n20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst', 'unitOfMeasure': 'log of min angle of resolution (logMAR)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Distance Visual Acuity in Sound Eye', 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.10', 'groupId': 'BG000'}, {'value': '0.07', 'spread': '0.10', 'groupId': 'BG001'}, {'value': '0.16', 'spread': '0.09', 'groupId': 'BG002'}, {'value': '0.15', 'spread': '0.11', 'groupId': 'BG003'}, {'value': '.09', 'spread': '.11', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.\n\n20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst', 'unitOfMeasure': 'log of min angle of resolution (logMAR)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Intereye Acuity Difference', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '4.3', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '8.3', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '8.6', 'spread': '2.2', 'groupId': 'BG003'}, {'value': '5.2', 'spread': '2.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Intereye difference defined as the difference between logMAR scores (amblyopic eye minus sound eye)', 'unitOfMeasure': 'logMAR lines', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Refractive Error in Amblyopic Eye (spherical equivalent/diopters)', 'classes': [{'categories': [{'measurements': [{'value': '4.99', 'spread': '1.66', 'groupId': 'BG000'}, {'value': '4.94', 'spread': '1.81', 'groupId': 'BG001'}, {'value': '5.25', 'spread': '2.09', 'groupId': 'BG002'}, {'value': '5.36', 'spread': '1.29', 'groupId': 'BG003'}, {'value': '5.05', 'spread': '1.72', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Spherical equivalent is defined as the sphere plus 1/2 the cylinder.', 'unitOfMeasure': 'diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Refractive Error in Sound Eye (spherical equivalent/diopters)', 'classes': [{'categories': [{'measurements': [{'value': '3.71', 'spread': '1.71', 'groupId': 'BG000'}, {'value': '3.54', 'spread': '1.86', 'groupId': 'BG001'}, {'value': '3.60', 'spread': '2.18', 'groupId': 'BG002'}, {'value': '3.71', 'spread': '1.58', 'groupId': 'BG003'}, {'value': '3.63', 'spread': '1.79', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Spherical equivalent is defined as the sphere plus 1/2 the cylinder.', 'unitOfMeasure': 'diopters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-15', 'studyFirstSubmitDate': '2006-04-14', 'resultsFirstSubmitDate': '2009-08-03', 'studyFirstSubmitQcDate': '2006-04-14', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-18', 'studyFirstPostDateStruct': {'date': '2006-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity Mean Score in the Amblyopic Eye', 'timeFrame': '18 weeks', 'description': 'Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in an Snellen equivalent acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.\n\n20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst'}, {'measure': 'Visual Acuity Distribution in the Amblyopic Eye', 'timeFrame': '18 weeks', 'description': 'Visual acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at 18 weeks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This visual acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.\n\n20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst'}, {'measure': 'Mean Change in Visual Acuity in the Amblyopic Eye', 'timeFrame': 'baseline to 18 weeks', 'description': 'Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.\n\nA positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.'}, {'measure': 'Distribution of Change in Visual Acuity in the Amblyopic Eye', 'timeFrame': 'baseline to 18 weeks', 'description': 'Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.\n\nA positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.'}], 'secondaryOutcomes': [{'measure': 'Randot Preschool Stereoacuity at 18 Weeks- Participants With All Causes of Amblyopia', 'timeFrame': '18 weeks', 'description': 'The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \\>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.'}, {'measure': 'Randot Preschool Stereoacuity at 18 Weeks- Anisometropic Participants Only', 'timeFrame': '18 weeks', 'description': 'The Randot Preschool Stereotest measures stereopsis from 800 to 40 seconds of arc on patients as young as 2 years of age. This Stereotest is designed as a matching game in which the patient matches pictures in a test booklet wearing special glasses. A subject can fail the pretest (not see any pictures) or can score \\>800 (the worst), 800, 400, 200, 100, 60, or 40 (the best) seconds of arc. If two shapes are identified correctly the patient progresses to the next lower stereoacuity level. A failed test occurs when the patient cannot identify any shapes.'}, {'measure': 'Mean Change in Visual Acuity in the Sound Eye', 'timeFrame': 'baseline to 18 weeks', 'description': 'Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.\n\nA positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.'}, {'measure': 'Distribution of Change in Visual Acuity in the Sound Eye', 'timeFrame': 'baseline to 18 weeks', 'description': 'Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. The score is converted to logMAR (log of min angle of resolution) for statistical analysis, and a difference between the scores is calculated.\n\nA positive difference indicates acuity was better at 18wks than at baseline; a negative difference indicates acuity was worse at 18wks than at baseline.'}, {'measure': 'Visual Acuity Distribution in the Sound Eye', 'timeFrame': '18 weeks', 'description': 'Acuity is measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol at baseline and at 18 wks resulting in a Snellen acuity score that can range from 20/16 to 20/800. This acuity score is converted to logMAR (log of min angle of resolution) for statistical analysis.\n\n20/16=-0.1 logMAR; best 20/20=0.0 logMAR; 20/25=0.1; 20/32=0.2; 20/40=0.3; 20/50=0.4; 20/63=0.5; 20/80=0.6; 20/100=0.7; 20/125=0.8; 20/160=0.9; 20/200=1.0; 20/250=1.1; 20/320=1.2; 20/400=1.3; 20/500=1.4; 20/640=1.5; 20/800=1.6; worst'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Amblyopia', 'Atropine', 'Plano lens'], 'conditions': ['Amblyopia']}, 'referencesModule': {'references': [{'pmid': '19139333', 'type': 'RESULT', 'citation': 'Pediatric Eye Disease Investigator Group. Pharmacological plus optical penalization treatment for amblyopia: results of a randomized trial. Arch Ophthalmol. 2009 Jan;127(1):22-30. doi: 10.1001/archophthalmol.2008.520.'}, {'pmid': '19541265', 'type': 'RESULT', 'citation': 'Repka MX, Kraker RT, Beck RW, Birch E, Cotter SA, Holmes JM, Hertle RW, Hoover DL, Klimek DL, Marsh-Tootle W, Scheiman MM, Suh DW, Weakley DR; Pediatric Eye Disease Investigator Group. Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials. J AAPOS. 2009 Jun;13(3):258-63. doi: 10.1016/j.jaapos.2009.03.002.'}, {'pmid': '22108357', 'type': 'DERIVED', 'citation': 'Wallace DK, Lazar EL, Melia M, Birch EE, Holmes JM, Hopkins KB, Kraker RT, Kulp MT, Pang Y, Repka MX, Tamkins SM, Weise KK; Pediatric Eye Disease Investigator Group. Stereoacuity in children with anisometropic amblyopia. J AAPOS. 2011 Oct;15(5):455-61. doi: 10.1016/j.jaapos.2011.06.007.'}, {'pmid': '20451898', 'type': 'DERIVED', 'citation': 'Repka M, Simons K, Kraker R; Pediatric Eye Disease Investigator Group. Laterality of amblyopia. Am J Ophthalmol. 2010 Aug;150(2):270-4. doi: 10.1016/j.ajo.2010.01.040. Epub 2010 May 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is:\n\n* To compare the effectiveness and safety of weekend atropine augmented with a plano lens for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.\n* To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine treatment with and without a plano lens.', 'detailedDescription': 'Atropine is an effective treatment of moderate amblyopia. Reduction of the plus sphere for the sound eye is an accepted method of enhancing and possibly accelerating the treatment effect. Demonstrating additional value of the plano lens in terms of speed of improvement will shorten the treatment period, possibly improving child and parental compliance, leading to improved overall outcomes for patients with amblyopia. If the plano lens leads to greater improvement, then there will be less permanent visual impairment in patients with a history of amblyopia. It also is important to determine if the use of a plano lens in conjunction with atropine has a deleterious effect on the sound eye, and if yes, how often this occurs.\n\nLittle is known about the pharmacologic treatment of severe amblyopia. This study will provide important prospectively determined outcome data at little additional expense.\n\nIn a study conducted by the Pediatric Eye Disease Investigator Group, A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia, the use of weekend atropine for moderate amblyopia was as effective as daily treatment. Intermittent atropine use (such as using it only on the weekends) has the theoretical potential benefit of the sound eye having some time each week during which cycloplegia is only partial. It is possible that allowing some loss of the cycloplegic effect over the course of each week may be safer for the sound eye.\n\nThe study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimes for the 18 week primary treatment period are: 1) Atropine 1% once each weekend day in the sound eye and 2) Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be 3 to less than 7 years old with amblyopia associated with strabismus, anisometropia, or both.\n* Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \\> 3 logMAR lines.\n* Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.\n\nExclusion Criteria:\n\n* Atropine treatment within 6 months of enrollment and other amblyopia treatment of any type (other than normal spectacle lenses) used within one month of enrollment\n* No myopia in amblyopic eye'}, 'identificationModule': {'nctId': 'NCT00315302', 'acronym': 'ATS8', 'briefTitle': 'Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old', 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': 'A Randomized Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye As Prescribed Treatments for Amblyopia in Children 3 to <7 Years Old', 'orgStudyIdInfo': {'id': 'NEI-115'}, 'secondaryIdInfos': [{'id': '2U10EY011751', 'link': 'https://reporter.nih.gov/quickSearch/2U10EY011751', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Atropine', 'description': 'Atropine 1% once each weekend day in the sound eye', 'interventionNames': ['Drug: Atropine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Atropine plus plano', 'description': 'Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye', 'interventionNames': ['Drug: Atropine', 'Device: Plano Lens']}], 'interventions': [{'name': 'Atropine', 'type': 'DRUG', 'description': 'Atropine 1% once each weekend day', 'armGroupLabels': ['Atropine', 'Atropine plus plano']}, {'name': 'Plano Lens', 'type': 'DEVICE', 'description': 'Plano lens for the sound eye', 'armGroupLabels': ['Atropine plus plano']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92831', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Southern California College of Optometry', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'David Weakley, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Texas Southwestern Medical Center'}, {'name': 'Susan A. Cotter, O.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Southern California College of Optometry at Marshall B. Ketchum University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jaeb Center for Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, PEDIG Coordinating Center', 'investigatorFullName': 'Ray Kraker', 'investigatorAffiliation': 'Jaeb Center for Health Research'}}}}