Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-03-08 @ 1:47 AM
Study NCT ID:
NCT02807350
Status:
COMPLETED
Last Update Posted:
2022-06-03
First Post:
2016-06-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rkraker@jaeb.org', 'phone': '(813)-975-8690', 'title': 'Raymond Kraker, Coordinating Center Director', 'organization': 'Jaeb Center for Health Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '18 months', 'description': 'Although no adverse events are anticipated as a result of overminus therapy or non-overminus spectacle wear, any new cases of amblyopia, constant esotropia, or constant exotropia at distance and near will be reported. No surgical procedures are part of the protocol and no treatments are being prescribed that are not part of usual care. Investigators will abide by local IRB reporting requirements.', 'eventGroups': [{'id': 'EG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere', 'otherNumAtRisk': 196, 'deathsNumAtRisk': 196, 'otherNumAffected': 47, 'seriousNumAtRisk': 196, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus', 'otherNumAtRisk': 190, 'deathsNumAtRisk': 190, 'otherNumAffected': 15, 'seriousNumAtRisk': 190, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Development of Esotropia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': '>1 Diopter of Myopic Shift', 'notes': 'DSMC found more participants experienced the myopia progression in the overminus group than the non-overminus group. DSMC agreed the additional myopia progression is not serious, but recommended that any overminus treatment be stopped.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': '2 or more line decrease in visual acuity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amblyopia treatment prescribed by 12 months', 'stats': [{'groupId': 'EG000', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 190, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Distance Control at 12-Months (On-Treatment Visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean Distance Control at 18-Months (Off-Treatment Visit)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With No Spontaneous Tropia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The number of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'No Spontaneous Tropia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 18 months', 'description': 'The proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Distance Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'title': '>1 Point', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': '>2 Points', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19', 'ciLowerLimit': '7', 'ciUpperLimit': '29', 'groupDescription': '\\>1 point analysis', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20', 'ciLowerLimit': '10', 'ciUpperLimit': '28', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '\\>2 points analysis'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Distance Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'title': '>1 Point', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': '>2 Points', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4', 'ciLowerLimit': '-7', 'ciUpperLimit': '15', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '\\>1 analysis'}, {'groupIds': ['OG000'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8', 'ciLowerLimit': '-2', 'ciUpperLimit': '17', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': '\\>2 analysis'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'The proportion of subjects with ≥1 point improvement in distance control between baseline and 18 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group.\n\nParticipants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint.\n\n* Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control.\n* Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day.\n\nNote: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group.\n\nParticipants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint.\n\n* Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control.\n* Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day.\n\nNote: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Near Control (12 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'title': '0 to <1 points', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': '1 to <2 points', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': '2 to <3 points', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': '3 to <4 points', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': '4 to 5 points', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Near Control (18 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'title': '0 to <1 points', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': '1 to <2 points', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': '2 to <3 points', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '3 to <4 points', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '4 to 5 points', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Near Control (12 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Near Control (18 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).', 'unitOfMeasure': 'points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Angle Magnitude (12 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '25.0', 'spread': '8.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.', 'unitOfMeasure': 'Prism Diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Angle Magnitude (18 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '24.0', 'spread': '11.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.', 'unitOfMeasure': 'Prism Diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stereoacuity at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.', 'unitOfMeasure': 'arcseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stereoacuity at 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '18 months', 'description': 'A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.', 'unitOfMeasure': 'arcseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compliance With Spectacle Wear (12 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'title': 'Excellent (76-100%)', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'Good (51-75%)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Fair (26-50%)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Poor (1-25%)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Prescribed not wearing (0%)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compliance With Spectacle Wear (18 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'title': 'Excellent (76-100%)', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}]}, {'title': 'Good (51-75%)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Fair (26-50%)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Poor (1-25%)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Prescribed not wearing (0%)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Parent Symptom Survey [12 Months]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'title': 'Did your child have headaches?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Almost Always', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Did your child have eyestrain?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Almost Always', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Did your child avoid reading?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Almost Always', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Did your child have blurry vision?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Almost Always', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Did your child look over their spectacles?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Almost Always', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Did your child take their spectacles off?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Almost Always', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Did your child complain about hurt ears/nose?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Almost Always', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 12 months', 'description': 'A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'When number analyzed differs from full population size, it indicates that those children were not wearing spectacles, and therefore could not answer the spectacle related questions.'}, {'type': 'SECONDARY', 'title': 'Parent Symptom Survey [18 Months]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'OG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'classes': [{'title': 'Did your child have headaches?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Almost always', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Did your child have eyestrain?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Almost always', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Did your child avoid reading?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Almost always', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Did your child have blurry vision?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Almost always', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Did your child look over their spectacles?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Almost always', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Did your child take their spectacles off?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Almost always', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Did your child complain about hurt ears/nose?', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Never', 'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}, {'title': 'Almost never', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Sometimes', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Often', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Almost always', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 18 months', 'description': 'A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'When number analyzed differs from full population size, it indicates that those children were not wearing spectacles, and therefore could not answer the spectacle related questions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'FG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}, {'groupId': 'FG001', 'numSubjects': '190'}]}, {'type': '6 mo Follow Up Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': '12 mo Follow Up Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': '15 mo Follow Up Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '155'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '35'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere\n\nOverminus treatment: spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere'}, {'id': 'BG001', 'title': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus\n\nNon-overminus treatment: spectacles with full cycloplegic refraction without overminus'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '3 to <7 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}]}]}, {'title': '7 to <11 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Black/African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Refractive Error', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': '>0.50 Diopters', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': '>-0.75 to 0.50 Diopters', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': '-0.75 to >-3.00 Diopters', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': '<=-3.00 Diopters', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Non Surgical Treatment of IXT', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}, {'title': 'Patching only', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}, {'title': 'Vision therapy only', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Patching plus other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Randot Preschool Stereoacuity test score at near', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}]}], 'categories': [{'title': '40-100 arcseconds', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}, {'title': '200-800 arcseconds', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Nil', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Eight participants in the overminus group (5%) and 7 in the nonoverminus group (7%) did not understand test instructions to complete the stereotest; therefore, their stereoacuity at baseline was missing.'}, {'title': 'Mean distance visual acuity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': '20/12 to 20/20', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '227', 'groupId': 'BG002'}]}, {'title': '20/25 to 20/32', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}, {'title': '20/40 to 20/50', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'IOD of distance visual acuity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': '0 lines', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}, {'title': '0.1 lines', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}, {'title': '0.2 lines', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Spectacle wear', 'classes': [{'title': 'Does not wear spectacles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}, {'title': 'Wearing spectacles for at least 1 week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Exotropia Control at Distance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': '0 to <1 points', 'measurements': [{'value': 'NA', 'comment': 'Eligibility criteria required distance control at baseline to be at least 2 points', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Eligibility criteria required distance control at baseline to be at least 2 points', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': '1 to <2 points', 'measurements': [{'value': 'NA', 'comment': 'Eligibility criteria required distance control at baseline to be at least 2 points', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Eligibility criteria required distance control at baseline to be at least 2 points', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': '2 to <3 points', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}, {'title': '3 to <4 points', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': '4 to 5 points', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Control of the exodeviation was measured at distance and near using the IXT Office Control Score, (Mohney, 2006) which ranges from 0 (phoria) to 5 (constant exotropia). Control levels 3-5 were assigned based on the duration of manifest exotropia during a 30-second period before any dissociation. If no exotropia was observed, control levels 0-2 were assigned based on the longest time to reestablishing fusion after 3 consecutive 10-second periods of dissociation. Control was measured at the beginning, middle, and end (3 tests) of a 20- to 40-minute office examination, and the mean was used.', 'unitOfMeasure': 'Participants'}, {'title': 'Exotropia Control at near', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': '0 to <1 points', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': '1 to <2 points', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': '2 to <3 points', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': '3 to <4 points', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': '4 to 5 points', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Control of the exodeviation was measured at distance and near using the IXT Office Control Score, (Mohney, 2006) which ranges from 0 (phoria) to 5 (constant exotropia). Control levels 3-5 were assigned based on the duration of manifest exotropia during a 30-second period before any dissociation. If no exotropia was observed, control levels 0-2 were assigned based on the longest time to reestablishing fusion after 3 consecutive 10-second periods of dissociation. Control was measured at the beginning, middle, and end (3 tests) of a 20- to 40-minute office examination, and the mean was used.', 'unitOfMeasure': 'Participants'}, {'title': 'PACT exodeviation at distance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No exodeviation (orthophoria)', 'measurements': [{'value': 'NA', 'comment': 'PACT at distance was required to be at least 15Δ for eligibility.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'PACT at distance was required to be at least 15Δ for eligibility.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': '1-9 Δ', 'measurements': [{'value': 'NA', 'comment': 'PACT at distance was required to be at least 15Δ for eligibility.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'PACT at distance was required to be at least 15Δ for eligibility.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}, {'title': '10-15 Δ', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': '16-18 Δ', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': '19-25 Δ', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}, {'title': '30-35 Δ', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': '40-45 Δ', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': '>= 50 Δ', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Esodeviation', 'measurements': [{'value': 'NA', 'comment': 'PACT at distance was required to be at least 15Δ for eligibility.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'PACT at distance was required to be at least 15Δ for eligibility.', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Δ= prism dipoters', 'unitOfMeasure': 'Participants'}, {'title': 'PACT Exodeviation at near', 'classes': [{'title': 'No Exodeviation (orthophoria)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '1-9 Δ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': '10-15 Δ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': '16-18 Δ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': '19-25 Δ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}, {'title': '30-35 Δ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': '40-45 Δ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': '>= 50 Δ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Esodeviation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Δ= prism diopters', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-22', 'size': 1135682, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-22T13:09', 'hasProtocol': True}, {'date': '2021-02-25', 'size': 402950, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-02T16:01', 'hasProtocol': False}, {'date': '2019-12-18', 'size': 233795, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-08-27T11:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 386}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2016-06-16', 'resultsFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2016-06-16', 'lastUpdatePostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-11', 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Distance Control at 12-Months (On-Treatment Visit)', 'timeFrame': '12 months', 'description': 'A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).'}, {'measure': 'Mean Distance Control at 18-Months (Off-Treatment Visit)', 'timeFrame': '18 months', 'description': 'A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With No Spontaneous Tropia', 'timeFrame': '12 months', 'description': 'The number of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.'}, {'measure': 'No Spontaneous Tropia', 'timeFrame': 'At 18 months', 'description': 'The proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.'}, {'measure': 'Change in Distance Control', 'timeFrame': '12 months', 'description': 'The proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).'}, {'measure': 'Change in Distance Control', 'timeFrame': '18 months', 'description': 'The proportion of subjects with ≥1 point improvement in distance control between baseline and 18 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).'}, {'measure': 'Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months)', 'timeFrame': '12 months', 'description': 'The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group.\n\nParticipants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint.\n\n* Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control.\n* Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day.\n\nNote: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.'}, {'measure': 'Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months)', 'timeFrame': '18 months', 'description': 'The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group.\n\nParticipants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint.\n\n* Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control.\n* Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day.\n\nNote: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.'}, {'measure': 'Near Control (12 Months)', 'timeFrame': '12 months', 'description': 'Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).'}, {'measure': 'Near Control (18 Months)', 'timeFrame': '18 months', 'description': 'Mean control of the near exodeviation (average of 3 measurements over the exam). The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).'}, {'measure': 'Change in Near Control (12 Months)', 'timeFrame': '12 months', 'description': 'For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).'}, {'measure': 'Change in Near Control (18 Months)', 'timeFrame': '18 months', 'description': 'For each timepoint, the change in near control since baseline will be reported. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (\\<50% score 3; \\>50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (\\>5 seconds score 2; 1-5 seconds score 1; \\<1 second score 0).'}, {'measure': 'Angle Magnitude (12 Months)', 'timeFrame': '12 months', 'description': 'The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.'}, {'measure': 'Angle Magnitude (18 Months)', 'timeFrame': '18 months', 'description': 'The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.'}, {'measure': 'Stereoacuity at 12 Months', 'timeFrame': '12 months', 'description': 'A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.'}, {'measure': 'Stereoacuity at 18 Months', 'timeFrame': '18 months', 'description': 'A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.'}, {'measure': 'Compliance With Spectacle Wear (12 Months)', 'timeFrame': '12 months', 'description': 'Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.'}, {'measure': 'Compliance With Spectacle Wear (18 Months)', 'timeFrame': '18 months', 'description': 'Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.'}, {'measure': 'Parent Symptom Survey [12 Months]', 'timeFrame': 'At 12 months', 'description': 'A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.'}, {'measure': 'Parent Symptom Survey [18 Months]', 'timeFrame': 'At 18 months', 'description': 'A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intermittent Exotropia', 'IXT', 'overminus'], 'conditions': ['Intermittent Exotropia']}, 'referencesModule': {'references': [{'pmid': '33662112', 'type': 'RESULT', 'citation': 'Chen AM, Erzurum SA, Chandler DL, Hercinovic A, Melia BM, Bhatt AR, Suh DW, Vricella M, Erickson JW, Miller AM, Marsh JD, Bodack MI, Martinson SR, Titelbaum JR, Gray ME, Holtorf HL, Kong L, Kraker RT, Rahmani B, Shah BK, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Apr 1;139(4):464-476. doi: 10.1001/jamaophthalmol.2021.0082.'}, {'pmid': '38536764', 'type': 'DERIVED', 'citation': 'Writing Committee for the Pediatric Eye Disease Investigator Group; Pediatric Eye Disease Investigator Group; Chen AM, Erzurum SA, Chandler DL, Hercinovic A, Wu R, Vricella M, Waters AL, Ticho BH, Erickson JW, Han S, McDowell PS, Li Z, Kraker RT, Holmes JM, Cotter SA. Refractive Error Change and Overminus Lens Therapy for Childhood Intermittent Exotropia. JAMA Ophthalmol. 2024 May 1;142(5):417-428. doi: 10.1001/jamaophthalmol.2024.0276.'}, {'pmid': '35412528', 'type': 'DERIVED', 'citation': 'Holmes JM, Leske DA, Hercinovic A, Hatt SR, Chandler DL, Li Z, Melia BM, Chen AM, Erzurum SA, Crouch ER, Jenewein EC, Kraker RT, Cotter SA; Pediatric Eye Disease Investigator Group. Rasch-calibrated Intermittent Exotropia Symptom Questionnaire for Children. Optom Vis Sci. 2022 Jun 1;99(6):513-520. doi: 10.1097/OPX.0000000000001901. Epub 2022 Apr 12.'}], 'seeAlsoLinks': [{'url': 'http://pedig.jaeb.org/', 'label': 'PEDIG public website'}]}, 'descriptionModule': {'briefSummary': 'The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine:\n\n* The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score.\n* The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).', 'detailedDescription': 'The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine:\n\n* The long-term on-treatment effect of overminus treatment on distance IXT control score.\n* The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).\n\nThe recently completed IXT3 pilot study (NCT02223650) addressed the question of whether overminus lens therapy has an initial short-term therapeutic effect for IXT while wearing overminus spectacles. There have been no rigorous studies that address the following important questions related to overminus lens therapy:\n\n* Does overminus lens therapy have a long-term therapeutic effect for IXT while wearing overminus spectacles (over many months or years)?\n* Does overminus lens therapy have a long-term therapeutic effect for IXT when overminus spectacles are discontinued?\n\nIn November 2019, a protocol amendment discontinued overminus lens treatment and extended the study for an additional 18 months after the 18-month randomized trial has ended. The objective of the extension study is to compare long-term refractive error between subjects originally treated with either overminus spectacles or non-overminus spectacles as part of the 18-month randomized trial; treatment is at investigator discretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 3 years to \\< 11 years\n* Intermittent exotropia (manifest deviation) meeting all of the following criteria:\n* At distance: intermittent exotropia or constant exotropia\n\n o Mean distance control score of 2 points or more (mean of 3 assessments over the exam)\n* At near: intermittent exotropia, exophoria, or orthophoria\n\n o Subject cannot have a score of 5 points on all 3 near assessments of control\n* Exodeviation at least 15∆ at distance measured by PACT\n* Near deviation does not exceed distance deviation by more than 10∆ by PACT (convergence insufficiency type IXT excluded)\n* Distance visual acuity (any optotype method) in each eye of 0.4 logMAR (20/50) or better if age 3 years and 0.3 logMAR (20/40) or better if 4 years or older.\n* Interocular difference of distance visual acuity ≤0.2 logMAR (2 lines on a logMAR chart)\n* Refractive error between -6.00 diopters (D) standard error (SE) and +1.00D SE (inclusive) in the most myopic / least hyperopic eye based on a cycloplegic refraction performed within the past 2 months or at the end of the enrollment exam.\n* If refractive error (based on cycloplegic refraction performed within past 2 months or at the end of the enrollment exam) meets any of the following criteria, then pre-study spectacles are required and must have been worn for at least 1 week prior to enrollment:\n* SE anisometropia ≥1.00D\n* Astigmatism ≥1.50D in either eye\n* SE myopia ≥-1.00D in either eye\n\nPre-study refractive correction, if worn, must meet the following criteria relative to the cycloplegic refraction performed within past 2 months or at the end of the enrollment exam:\n\n* SE anisometropia must be corrected within \\<1.00D of the SE anisometropic difference\n* Astigmatism must be corrected within \\<1.00D of full magnitude; axis must be within 10 degrees.\n* The SE of the spectacles must not meet the definition of substantial overminus (see exclusion criteria below)\n* Gestational age ≥ 32 weeks\n* Birth weight \\> 1500 grams\n* Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus spectacles\n* Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff and Investigator's site staff\n* Relocation outside of area of an active PEDIG site within next 18 months is not anticipated\n\nExclusion Criteria:\n\n* Treatment for IXT or amblyopia (other than refractive correction) within the past 4 weeks, including vision therapy, patching, atropine, or other penalization.\n* Current contact lens wear\n* Substantial deliberate overminus treatment within the past 6 months, defined as spectacles overminused by more than 1.00D SE than the cycloplegic refractive error (within 2 months or at the end of the enrollment exam)\n* Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)\n* Abnormality of the cornea, lens, or central retina\n* Down syndrome or cerebral palsy\n* Severe developmental delay which would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delays or reading and/or learning disabilities are not excluded.\n* Any disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, dysautonomia, myasthenia gravis, or current use of atropine for amblyopia\n* Anti-seizure medications \\[e.g., carbamazepine (Tegretol, Carbatrol, Epitol, or Equetro), diazepam (Valium or Diastat), clobazam (Frisium or Onfri), clonazepam (Klonopin), lorazepam (Ativan), ethosuximide (Zarontin), felbamate (Felbatol), lacosamide (VIMPAT), gabapentin (Neurontin), oxcarbazepine (Oxtellar XR or Trileptal), phenobarbital, phenytoin (Dilantin or Phenytek), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), or zonisamide (Zonegran), vigabatrin (Sabril)\\]"}, 'identificationModule': {'nctId': 'NCT02807350', 'acronym': 'IXT5', 'briefTitle': 'Trial of Overminus Spectacle Therapy for Intermittent Exotropia', 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': 'A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia', 'orgStudyIdInfo': {'id': 'IXT5'}, 'secondaryIdInfos': [{'id': '2U10EY011751', 'link': 'https://reporter.nih.gov/quickSearch/2U10EY011751', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Overminus Treatment', 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere', 'interventionNames': ['Device: Overminus treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-overminus Treatment', 'description': 'spectacles with full cycloplegic refraction without overminus', 'interventionNames': ['Device: Non-overminus treatment']}], 'interventions': [{'name': 'Overminus treatment', 'type': 'DEVICE', 'otherNames': ['Overminus spectacles', 'Overminus glasses', 'Overminus therapy'], 'description': 'spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere', 'armGroupLabels': ['Overminus Treatment']}, {'name': 'Non-overminus treatment', 'type': 'DEVICE', 'description': 'spectacles with full cycloplegic refraction without overminus', 'armGroupLabels': ['Non-overminus Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Midwestern University Eye Institute', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Childrens', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92807', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'University Eye Center at Ketchum Health', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92831', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Marshall B. Ketchum University', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Health Care, Dept. of Ophthalmology', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Saddleback Eye Medical Associates', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '91766', 'city': 'Pomona', 'state': 'California', 'country': 'United States', 'facility': 'Western University College of Optometry', 'geoPoint': {'lat': 34.05529, 'lon': -117.75228}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Department of Ophthalmology', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33382', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova Southeastern University College of Optometry, The Eye Institute', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Eye Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "St Luke's Hospital", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois College of Optometry', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60415', 'city': 'Chicago Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Eye Specialists Center, LLC', 'geoPoint': {'lat': 41.70142, 'lon': -87.77922}}, {'zip': '60515', 'city': 'Downers Grove', 'state': 'Illinois', 'country': 'United States', 'facility': 'Midwestern U Chicago College of Optometry', 'geoPoint': {'lat': 41.80892, 'lon': -88.01117}}, {'zip': '60091', 'city': 'Wilmette', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pediatric Eye Associates', 'geoPoint': {'lat': 42.07225, 'lon': -87.72284}}, {'zip': '47405', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University School Of Optometry', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46321', 'city': 'Munster', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Eye Specialist Center, LLC', 'geoPoint': {'lat': 41.56448, 'lon': -87.51254}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Wolfe Eye Clinic', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Department of Neurology', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21204-5809', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Greater Baltimore Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287-9028', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Wilmer Eye Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "Helen DeVos Children's Hospital Pediatric Ophthalmology", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pediatric Ophthalmology, P.C.', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '48322', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Eye Care PC", 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Department of Ophthalmology', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospitals and Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63121', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'U of MO St. Louis College of Optometry', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '03301', 'city': 'Concord', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Concord Ophthalmologic Associates', 'geoPoint': {'lat': 43.20814, 'lon': -71.53757}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York, College of Optometry', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Eye Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': "Akron Children's Hospital", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210-1280', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University College of Optometry', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '44514', 'city': 'Poland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Eye Care Associates, Inc.', 'geoPoint': {'lat': 41.02423, 'lon': -80.6148}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Dean A. McGee Eye Institute, University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97205', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Pacific University College of Optometry', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Casey Eye Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17601', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Conestoga Eye', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Salus University/Pennsylvania College of Optometry', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "UPMC Children's Eye Center of Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina, Storm Eye Institute', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Pediatric Eye Specialists', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southern College of Optometry', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital - Dept. 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