Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT00320593
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2006-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Correction of Myopia Evaluation Trial 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}, {'id': 'D012030', 'term': 'Refractive Errors'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pedig@jaeb.org', 'phone': '813-875-8690', 'title': 'Raymond Kraker, MSPH', 'organization': 'Jaeb Center for Health Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations include: differential loss to follow up , differential compliance between the groups, power of near addition was not customized in PAL group, and we have no data on whether PAL group was looking through the near addition.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected through the 3-year outcome visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition', 'otherNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses', 'otherNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Distribution of Spherical Equivalent Refractive Error at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'OG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}], 'classes': [{'title': 'Better than or equal to -0.49 D', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '-0.50 to -0.99 D', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '-1.00 to -1.99 D', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '-2.00 to -2.99 D', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': '-3.00 to -3.99 D', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Worse than or equal to -4.00 D', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis followed the intent-to-treat principle.'}, {'type': 'PRIMARY', 'title': 'Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'OG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}], 'classes': [{'title': '>0.00 D (less myopia)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '0.00 to -0.49 D', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '-0.50 to -0.99 D', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '-1.00 to -1.49 D', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '<= -1.50 D (more myopia)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis followed the intent-to-treat principle.'}, {'type': 'SECONDARY', 'title': 'Mean Spherical Equivalent Refractive Error at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'OG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.41', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '-2.60', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.', 'unitOfMeasure': 'diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis followed the intent-to-treat principle.'}, {'type': 'PRIMARY', 'title': 'Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'OG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-1.15', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.55', 'groupDescription': 'The primary analysis was a comparison of treatment groups using an analysis of covariance (ANCOVA) model in which myopia at 3 years was adjusted for myopia at baseline and prior SVL wear. The sample size was computed to reach a 90% power and type I error rate of 5%, so that a difference in 3-year myopia progression between treatment groups would be detected if the true difference was at least 0.60 D, assuming a standard deviation of 0.85 D in each group and loss of follow up of 10%.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.53', 'groupDescription': 'An adjusted analysis for the treatment group difference of change in spherical equivalent from baseline to 3 years was performed by including in an analysis of covariance (ANCOVA) model the following covariates in addition to baseline myopia and prior single vision lens wear, which are known to be related to myopia progression: age, sex, ethnicity, accommodative lag, and magnitude of near esophoria.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.', 'unitOfMeasure': 'diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All analyses followed the intent-to-treat principle. The Monte Carlo Markov Chain (MCMC) method of multiple imputation was used to impute data for subjects who did not complete the 3-year visit.'}, {'type': 'SECONDARY', 'title': 'Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'OG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}], 'classes': [{'title': 'Age at baseline: 8 to <9 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Age at baseline: 9 to <10 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Age at baseline: 10 to <11 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Age at baseline: 11 to <12 years', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Gender: Male', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Gender: Female', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Race/Ethnicity: White', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Race/Ethnicity: Nonwhite', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Prior spectacle wear: Currently or in past', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Prior spectacle wear: Never', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Spherical equivalent at baseline: -0.75 to -1.49 D', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Spherical equivalent at baseline: -1.50 to -2.50 D', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Accommodative lag at baseline: 0.50 to 1.49 D', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Accommodative lag at baseline: 1.50 or worse', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Near esophoria at baseline: 2 to 5 PD', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Near esophoria at baseline: 6 to 10 PD', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Near esophoria at baseline: >10 PD', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Parental history of myopia: Neither parent', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Parental history of myopia: One parent', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Parental history of myopia: Both parents', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis followed the intent-to-treat principle.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'OG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}], 'classes': [{'title': 'Age at baseline: 8 to <9 years', 'categories': [{'measurements': [{'value': '-1.23', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-1.39', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Age at baseline: 9 to <10 years', 'categories': [{'measurements': [{'value': '-1.11', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-1.14', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Age at baseline: 10 to <11 years', 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Age at baseline: 11 to <12 years', 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '0.58', 'groupId': 'OG001'}]}]}, {'title': 'Gender: Male', 'categories': [{'measurements': [{'value': '-0.95', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Gender: Female', 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-1.21', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Race/Ethnicity: White', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Race/Ethnicity: Nonwhite', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Prior spectacle wear: Currently or in past', 'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Prior spectacle wear: Never', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Spherical equivalent at baseline: -0.75 to -1.49 D', 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Spherical equivalent at baseline: -1.50 to -2.50 D', 'categories': [{'measurements': [{'value': '-0.93', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-1.08', 'spread': '0.75', 'groupId': 'OG001'}]}]}, {'title': 'Accommodative lag at baseline: 0.50 to 1.49 D', 'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Accommodative lag at baseline: 1.50 or worse', 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Near esophoria at baseline: 2 to 5 PD', 'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Near esophoria at baseline: 6 to 10 PD', 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '-1.09', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Near esophoria at baseline: >10 PD', 'categories': [{'measurements': [{'value': '-1.01', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Parental history of myopia: Neither parent', 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Parental history of myopia: One parent', 'categories': [{'measurements': [{'value': '-0.73', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-1.28', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Parental history of myopia: Both parents', 'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '0.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.', 'unitOfMeasure': 'diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis followed the intent-to-treat principle.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'OG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.005', 'ciUpperLimit': '0.28', 'groupDescription': 'A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 1 year, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 1 year, in which myopia at 1 year was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 1 year values were known) were included.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 1 year', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 1 year, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 1 year. A negative value indicates that the myopia worsened; a positive value indicates that it improved.', 'unitOfMeasure': 'diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis followed the intent-to-treat principle.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'OG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.45', 'groupDescription': 'A secondary analysis was conducted to assess the treatment effect on myopia at the interim time point of 2 years, using an analysis of covariance (ANCOVA) model for the treatment group difference of change in spherical equivalent refractive error from baseline to 2 years, in which myopia at 2 years was adjusted for myopia at baseline and prior single vision lenses wear. Only complete cases (cases in which both baseline and 2 year values were known) were included.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 2 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 2 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 2 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.', 'unitOfMeasure': 'diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis followed the intent-to-treat principle'}, {'type': 'SECONDARY', 'title': 'Excellent Spectacle Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'OG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}], 'classes': [{'title': 'During school', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'After school', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Weekends', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 3 years', 'description': 'Spectacle compliance was assessed on a five-point Likert scale: always, 5; often, 4; sometimes, 3; rarely, 2; and never, 1. Excellent compliance indicates that for the specified period (during school, after school, on weekends), spectacles were estimated at all visits to have been worn either always or often.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis followed the intent-to-treat principle. Two patients had no compliance data because they had no follow-up visits (one single vision lenses, and one progressive-addition lenses).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'FG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed defined as completing the 3 year primary outcome exam', 'groupId': 'FG000', 'numSubjects': '52'}, {'comment': 'Completed defined as completing the 3 year primary outcome exam', 'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Moved to another state', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by clinical center', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Between April 2005 and March 2007, 118 subjects age 8 to \\<12 years were enrolled in the study at 8 clinical centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Progressive Addition Lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition'}, {'id': 'BG001', 'title': 'Single Vision Lenses (SVLs)', 'description': 'Standard single vision lenses'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.2', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '10.0', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '10.1', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Age at enrollment', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '8 to <9 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': '9 to <10 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': '10 to <11 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': '11 to <12 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Age at enrollment', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Spectacle wear (single vision lenses)', 'classes': [{'title': 'Currently', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'In past but not currently', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Average Spherical Equivalent Between the Eyes', 'classes': [{'title': '-0.75 to -0.99 diopters (D)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': '-1.00 to -1.49 D', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': '-1.50 to -1.99 D', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': '-2.00 to -2.50 D', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). Spherical equivalent is defined as the sphere plus 1/2 the cylinder. A spherical equivalent was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the spherical equivalent used for analysis.', 'unitOfMeasure': 'participants'}, {'title': 'Average Spherical Equivalent Between the Eyes', 'classes': [{'categories': [{'measurements': [{'value': '-1.50', 'spread': '0.45', 'groupId': 'BG000'}, {'value': '-1.45', 'spread': '0.47', 'groupId': 'BG001'}, {'value': '-1.48', 'spread': '0.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). Spherical equivalent is defined as the sphere plus 1/2 the cylinder. A spherical equivalent was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the spherical equivalent used for analysis.', 'unitOfMeasure': 'diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average J0 Between the Eyes', 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.18', 'groupId': 'BG000'}, {'value': '-0.02', 'spread': '0.15', 'groupId': 'BG001'}, {'value': '-0.02', 'spread': '0.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). The dioptric power of a Jackson cross cylinder with axis at 0 degrees (J0) is calculated using the power vector approach. A J0 was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the J0 used for analysis.', 'unitOfMeasure': 'diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average J45 Between the Eyes', 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '0.07', 'groupId': 'BG000'}, {'value': '0.10', 'spread': '0.07', 'groupId': 'BG001'}, {'value': '0.11', 'spread': '0.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). The dioptric power of a Jackson cross cylinder with axis at 45 degrees (J45) is calculated using the power vector approach. A J45 was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the J45 used for analysis.', 'unitOfMeasure': 'diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Anisometropia', 'classes': [{'categories': [{'measurements': [{'value': '0.22', 'spread': '0.20', 'groupId': 'BG000'}, {'value': '0.21', 'spread': '0.16', 'groupId': 'BG001'}, {'value': '0.22', 'spread': '0.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. In this study, sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle from 0 to 180 degrees (axis). Anisometropia is defined as spherical equivalent in the right eye subtracted by spherical equivalent in the left eye.', 'unitOfMeasure': 'diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Near Esophoria', 'classes': [{'title': '2 to 5 prism diopters (PD)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': '6 to 10 PD', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': '11 to 15 PD', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '16 to 20 PD', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Measured in prism diopters (PD) using the Prism and Alternate Cover Test (PACT) at 33 cm. Esophoria is the tendency of the eyes to deviate inwards when fusion between the eyes is suspended. Near esophoria is an esophoria when viewing close objects.', 'unitOfMeasure': 'participants'}, {'title': 'Near Esophoria', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '5.9', 'spread': '3.4', 'groupId': 'BG001'}, {'value': '5.9', 'spread': '3.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured in prism diopters (PD) using the Prism and Alternate Cover Test (PACT) at 33 cm. Esophoria is the tendency of the eyes to deviate inwards when fusion between the eyes is suspended. Near esophoria is an esophoria when viewing close objects.', 'unitOfMeasure': 'prism diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Accommodative Lag', 'classes': [{'title': '0.50 to 0.99 diopters (D)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': '1.00 to 1.49 D', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': '1.50 to 1.99 D', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': '2.00 D or more', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle (axis). Accommodative lag is the average of the median accommodative lag of the five trials of the right eye. To determine the accommodative lag or accommodative lead, the accommodative measurement was added to the 3.00-D demand to result in the accommodative lag or lead. If the value was positive, it indicated accommodative lag; if the number was negative, it indicated accommodative lead.', 'unitOfMeasure': 'participants'}, {'title': 'Accommodative Lag', 'classes': [{'categories': [{'measurements': [{'value': '1.47', 'spread': '0.53', 'groupId': 'BG000'}, {'value': '1.40', 'spread': '0.48', 'groupId': 'BG001'}, {'value': '1.44', 'spread': '0.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere, cylinder, and axis. Sphere refers to the amount of myopia (nearsightedness) and cylinder the amount of astigmatism at a particular angle (axis). Accommodative lag is the average of the median accommodative lag of the five trials of the right eye. To determine the accommodative lag or accommodative lead, the accommodative measurement was added to the 3.00-D demand to result in the accommodative lag or lead. If the value was positive, it indicated accommodative lag; if the number was negative, it indicated accommodative lead.', 'unitOfMeasure': 'diopters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Parental History of Myopia', 'classes': [{'title': 'Neither parent', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'One parent', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Both parents', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Missing/unknown', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-15', 'studyFirstSubmitDate': '2006-04-28', 'resultsFirstSubmitDate': '2011-05-17', 'studyFirstSubmitQcDate': '2006-04-28', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-17', 'studyFirstPostDateStruct': {'date': '2006-05-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years', 'timeFrame': 'Baseline to 3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.'}, {'measure': 'Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years', 'timeFrame': '3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and each time point, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.'}], 'secondaryOutcomes': [{'measure': 'Distribution of Spherical Equivalent Refractive Error at 3 Years', 'timeFrame': '3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.'}, {'measure': 'Mean Spherical Equivalent Refractive Error at 3 Years', 'timeFrame': '3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. A SE was calculated for each eye for each of the five trials of cycloplegic autorefraction, and the median for each eye was averaged to obtain the SE used for analysis.'}, {'measure': 'Distribution of Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics', 'timeFrame': 'Baseline to 3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.'}, {'measure': 'Mean Change in Spherical Equivalent Refractive Error From Baseline to 3 Years According to Baseline Characteristics', 'timeFrame': 'Baseline to 3 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 3 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 3 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.'}, {'measure': 'Mean Change in Spherical Equivalent Refractive Error From Baseline to 1 Year', 'timeFrame': 'Baseline to 1 year', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 1 year, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 1 year. A negative value indicates that the myopia worsened; a positive value indicates that it improved.'}, {'measure': 'Mean Change in Spherical Equivalent Refractive Error From Baseline to 2 Years', 'timeFrame': 'Baseline to 2 years', 'description': 'Measured in diopters (D) using cycloplegic refraction sphere (amount of myopia) and cylinder (amount of astigmatism at an angle (axis)). Spherical equivalent (SE) is defined as the sphere plus 1/2 the cylinder. For baseline and 2 years, a SE was calculated for each eye for each of the five trials of cycloplegic autorefraction; the median for each eye was averaged to obtain the SE used for analysis. Change was calculated as SE at baseline minus SE at 2 years. A negative value indicates that the myopia worsened; a positive value indicates that it improved.'}, {'measure': 'Excellent Spectacle Compliance', 'timeFrame': 'Baseline to 3 years', 'description': 'Spectacle compliance was assessed on a five-point Likert scale: always, 5; often, 4; sometimes, 3; rarely, 2; and never, 1. Excellent compliance indicates that for the specified period (during school, after school, on weekends), spectacles were estimated at all visits to have been worn either always or often.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myopia', 'Progressive Addition Lenses (PALs)', 'Single Vision Lenses (SVLs)', 'Accommodative lags', 'Near esophoria', 'Refractive error'], 'conditions': ['Myopia']}, 'referencesModule': {'references': [{'pmid': '19214130', 'type': 'RESULT', 'citation': 'Correction of Myopia Evaluation Trial 2 Study Group for the Pediatric Eye Disease Investigator Group; Manny RE, Chandler DL, Scheiman MM, Gwiazda JE, Cotter SA, Everett DF, Holmes JM, Hyman LG, Kulp MT, Lyon DW, Marsh-Tootle W, Matta N, Melia BM, Norton TT, Repka MX, Silbert DI, Weissberg EM. Accommodative lag by autorefraction and two dynamic retinoscopy methods. Optom Vis Sci. 2009 Mar;86(3):233-43. doi: 10.1097/OPX.0b013e318197180c.'}, {'pmid': '21282579', 'type': 'RESULT', 'citation': 'Correction of Myopia Evaluation Trial 2 Study Group for the Pediatric Eye Disease Investigator Group. Progressive-addition lenses versus single-vision lenses for slowing progression of myopia in children with high accommodative lag and near esophoria. Invest Ophthalmol Vis Sci. 2011 Apr 25;52(5):2749-57. doi: 10.1167/iovs.10-6631.'}, {'pmid': '36809645', 'type': 'DERIVED', 'citation': 'Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if progressive addition lenses (PALs) versus single vision lenses (SVLs) slow the progression of low myopia in children with poor accommodative responses (i.e., large accommodative lags) and near esophoria.', 'detailedDescription': 'Myopia is a significant public health problem that affects at least 34% of children in the United States and a much higher percentage in Asia. It is a predisposing factor for retinal detachment, myopic retinopathy, and glaucoma, thus contributing to loss of vision and blindness. As might be expected for such a prevalent condition, treatment costs are high. If interventions to retard myopia progression are successful, sight-threatening complications might be avoided and costs should be reduced.\n\nThe study has been designed as a simple trial that, other than the type of lenses being determined through the randomization process and the addition of accommodation testing using an autorefractor, largely approximates standard clinical practice.\n\nScreening consists of non-cycloplegic procedures of subjective refraction, testing of oculomotor alignment, and testing of accommodative response using the Grand Seiko autorefractor.\n\nPatients who appear to be eligible for the randomized trial will be tested with their eyes dilated to determine whether refractive error in each eye is within the eligibility range for the randomized trial. Patients will be randomized to either progressive addition lenses (PALs) with a +2.00 D addition or to single vision lenses (SVLs). Children will have three years of follow up, with visits every 6 months.\n\nThe primary outcome visit is timed 3 years from randomization, with the primary analysis being a comparison of the average change from baseline to 3 years in amount of myopia between children in the single-vision lens group and the children in the progressive-addition lens group. The primary outcome is change in spherical equivalent refractive error (SER) in diopters (D) as measured by cycloplegic autorefraction.\n\nA separate ancillary study nested within the screening process will collect data on two additional methods of measuring accommodation, Monocular Estimate Method (MEM) retinoscopy and Nott retinoscopy. The aim of the ancillary study to help determine whether a simple, effective measure exists that can be easily used by clinicians to identify children with reduced accommodative response who, if they have low myopia and esophoria, might benefit from the treatment with PALs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractive error determined by cycloplegic autorefraction which meets all of the following:\n\n 1. Spherical equivalent: -0.50 to -3.00 D in both eyes\n 2. Astigmatism \\<= 1.5 D in both eyes\n 3. Anisometropia \\<= 1.00 D difference between eyes in spherical equivalent\n* Visual acuity is at least 20/20 with best subjective refraction in both eyes\n* Accommodative response at near (33 cm) is less than 2.0D by non-cycloplegic autorefraction\n* Near esophoria (\\>= 2.0 PD) present by alternate prism and cover test (APCT) at near using best refractive correction determined from non-cycloplegic subjective refraction\n\nExclusion Criteria:\n\n* Strabismus present by cover-uncover test at far, near, and/or near with +2.00D over best subjective refraction\n* Current or prior use of PALs, bifocals, or contact lenses in either eye (prior or current use of SVLs is allowed)'}, 'identificationModule': {'nctId': 'NCT00320593', 'acronym': 'COMET2', 'briefTitle': 'Correction of Myopia Evaluation Trial 2', 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': 'Correction of Myopia Evaluation Trial 2 (COMET2): A Randomized Trial of the Effect of Progressive Addition Lenses Versus Single Vision Lenses on Low Myopia Associated With Large Accommodative Lags and Near Esophoria in Children', 'orgStudyIdInfo': {'id': 'NEI-123'}, 'secondaryIdInfos': [{'id': '2U10EY011751', 'link': 'https://reporter.nih.gov/quickSearch/2U10EY011751', 'type': 'NIH'}, {'id': '5U10EY011751', 'link': 'https://reporter.nih.gov/quickSearch/5U10EY011751', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Progressive addition lenses (PALs)', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition', 'interventionNames': ['Device: Progressive Addition Lenses (PALs)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single vision lenses (SVLs)', 'description': 'Single vision lenses', 'interventionNames': ['Device: Single Vision Lenses (SVLs)']}], 'interventions': [{'name': 'Progressive Addition Lenses (PALs)', 'type': 'DEVICE', 'description': 'Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition', 'armGroupLabels': ['Progressive addition lenses (PALs)']}, {'name': 'Single Vision Lenses (SVLs)', 'type': 'DEVICE', 'description': 'Single vision lenses', 'armGroupLabels': ['Single vision lenses (SVLs)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama- Birmingham, School of Optometry', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92831-1699', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Southern California College of Optometry', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana School of Optometry', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '02215-3468', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England College of Optometry', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '43210-1280', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University College of Optometry', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17601', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Family Eye Group', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania College of Optometry', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77204-2020', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Houston College of Optometry', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jane E Gwiazda, Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'New England College of Optometry'}, {'name': 'Wendy L Marsh-Tootle', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham School of Optometry'}, {'name': 'Ruth E Manny', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Houston College of Optometry'}, {'name': 'Erik M Weissberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New England College of Optometry'}, {'name': 'David I Silbert', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Family Eye Group'}, {'name': 'Don W Lyon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}, {'name': 'Mitchell M Scheiman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennsylvania College of Optometry'}, {'name': 'Marjean T Kulp', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}, {'name': 'Susan A Cotter', 'role': 'PRINCIPAL_INVESTIGATOR', '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': 'SPONSOR'}}}}