Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-01-11 @ 3:11 PM
Study NCT ID:
NCT00472212
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2007-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Correction of Farsightedness in Children Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kulp.6@osu.edu', 'phone': '614-688-3336', 'title': 'Marjean Kulp', 'organization': 'The Ohio State University College of Optometry'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Glasses With Hyperopic Lenses', 'description': 'Spectacles with hyperopic lenses\n\nSpectacles: Hyperopic spectacle lenses', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Spectacles with placebo lenses\n\nControl: Plano (no power, control) spectacle lenses', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glasses With Hyperopic Lenses', 'description': 'Glasses with hyperopic lenses (Correction)'}, {'id': 'OG001', 'title': 'Control', 'description': 'Glasses with placebo lenses\n\nControl: Glasses with plano (no power, control) spectacle lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.92', 'groupId': 'OG000', 'lowerLimit': '-7.9', 'upperLimit': '2.1'}, {'value': '0.088', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '5.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 week outcome exam', 'description': 'The Kaufman Test of Educational Achievement (K-TEA) was used to measure change in reading skill (reading comprehension). The K-TEA is a well-established, individually administered, standardized test for assessment of achievement in reading, with a mean standard score of 100 and standard deviation of 15. Higher values represent better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glasses With Hyperopic Lenses', 'description': 'Glasses with hyperopic lenses (Correction)'}, {'id': 'OG001', 'title': 'Control', 'description': 'Glasses with placebo lenses\n\nControl: Glasses with plano (no power, control) spectacle lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '9.14', 'groupId': 'OG000', 'lowerLimit': '4.8', 'upperLimit': '13.5'}, {'value': '3.46', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '7.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 week outcome exam', 'description': 'Individually administered battery designed to measure cognitive processing abilities. CAS is based on PASS (Planning, Attention, Simultaneous, and Successive), a well-researched cognitive/neuropsychological theory.\n\nA higher score indicates a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Glasses With Hyperopic Lenses', 'description': 'Glasses with hyperopic lenses (Correction)'}, {'id': 'OG001', 'title': 'Control', 'description': 'Glasses with placebo lenses\n\nControl: Glasses with plano (no power, control) spectacle lenses'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '-0.068', 'upperLimit': '0.53'}, {'value': '0.054', 'groupId': 'OG001', 'lowerLimit': '-0.25', 'upperLimit': '0.36'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 week outcome exam', 'description': 'Accommodative response, Right eye. This is a measure the accuracy of focusing (accommodative accuracy or response) while the subject views a near target. Lower (positive) values represent better accuracy of focusing.', 'unitOfMeasure': 'Diopters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Glasses With Hyperopic Lenses', 'description': 'Spectacles with hyperopic lenses\n\nSpectacles: Hyperopic spectacle lenses'}, {'id': 'FG001', 'title': 'Control', 'description': 'Spectacles with placebo lenses\n\nControl: Plano (no power, control) spectacle lenses'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Glasses With Hyperopic Lenses', 'description': 'Spectacles with hyperopic lenses\n\nSpectacles: Hyperopic spectacle lenses'}, {'id': 'BG001', 'title': 'Control', 'description': 'Spectacles with placebo lenses\n\nControl: Plano (no power, control) spectacle lenses'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.58', 'spread': '1.78', 'groupId': 'BG000'}, {'value': '7.41', 'spread': '1.47', 'groupId': 'BG001'}, {'value': '7.5', 'spread': '1.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'One subject with race /ethnicity not reported'}, {'title': 'Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95.17', 'spread': '13.47', 'groupId': 'BG000'}, {'value': '97.07', 'spread': '13.38', 'groupId': 'BG001'}, {'value': '96.09', 'spread': '13.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline vision and baseline educational testing completed at separate visits. The Kaufman Test of Educational Achievement (K-TEA) was used to measure change in reading skills (decoding and reading comprehension). The K-TEA is a well-established, individually administered, standardized test for assessment of achievement in reading, with a mean standard score of 100 and standard deviation of 15. Higher values represent better performance.', 'unitOfMeasure': 'units on a scale (standard score)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Test results not available for two subjects.'}, {'title': 'Cognitive Assessment System (CAS) Attention Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '97.83', 'spread': '17.09', 'groupId': 'BG000'}, {'value': '101.96', 'spread': '19.52', 'groupId': 'BG001'}, {'value': '99.82', 'spread': '18.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline vision and baseline educational testing completed at separate visits. The Cognitive Assessment System (CAS) is a well-researched, norm-referenced measure of cognitive ability. Standard scores are normed to a mean of 100 and a standard deviation of 15 for each battery. The CAS attention battery (Expressive Attention, Number Detection, and Receptive Attention) require the participant to selectively attend to a particular stimulus and inhibit attending to competing stimuli. Higher values represent better performance.', 'unitOfMeasure': 'units on a scale (standard score)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Test results not available for 2 subjects.'}, {'title': 'Accommodative Response by monocular estimation method (MEM)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.42', 'groupId': 'BG000'}, {'value': '0.67', 'spread': '0.45', 'groupId': 'BG001'}, {'value': '0.69', 'spread': '0.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Accommodative response, Right eye. Baseline vision and educational testing completed on separate dates. This technique is used to measure the accuracy of focusing (accommodative response) while the subject views a near target. Lower (positive) values represent better accuracy of focusing.', 'unitOfMeasure': 'diopters', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-21', 'studyFirstSubmitDate': '2007-05-09', 'resultsFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2007-05-10', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-05', 'studyFirstPostDateStruct': {'date': '2007-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Kaufman Test of Educational Achievement (K-TEA) Reading Comprehension Score as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)', 'timeFrame': '6 week outcome exam', 'description': 'The Kaufman Test of Educational Achievement (K-TEA) was used to measure change in reading skill (reading comprehension). The K-TEA is a well-established, individually administered, standardized test for assessment of achievement in reading, with a mean standard score of 100 and standard deviation of 15. Higher values represent better performance.'}], 'secondaryOutcomes': [{'measure': 'Change in Cognitive Assessment System (CAS) Attention Scores as Measured From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)', 'timeFrame': '6 week outcome exam', 'description': 'Individually administered battery designed to measure cognitive processing abilities. CAS is based on PASS (Planning, Attention, Simultaneous, and Successive), a well-researched cognitive/neuropsychological theory.\n\nA higher score indicates a better outcome.'}, {'measure': 'Change in Accommodative Response From Baseline to After 6 Weeks of Assigned Treatment (Hyperopic or Control Correction)', 'timeFrame': '6 week outcome exam', 'description': 'Accommodative response, Right eye. This is a measure the accuracy of focusing (accommodative accuracy or response) while the subject views a near target. Lower (positive) values represent better accuracy of focusing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperopia', 'Farsightedness']}, 'descriptionModule': {'briefSummary': 'The Correction of Hyperopia In Children Study (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle correction for moderate amounts of hyperopia on visual function, attention, and reading skills in children.', 'detailedDescription': 'Hyperopia (farsightedness) has been reported to be associated with reduced visual perceptual and reading abilities. However, there is controversy regarding whether or not to prescribe for low to moderate amounts of hyperopia. The Correction of Hyperopia In Children Study (CHICS) is a placebo-controlled, randomized, masked investigation of the effect of spectacle correction for moderate amounts of hyperopia on visual function, attention, and reading skills in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 6-11 years;\n* At least +1.00D Hyperopia (farsightedness);\n* \\< +4.00D Hyperopia;\n* \\< 1.00D Astigmatism;\n* \\< 1.00D Anisometropia (difference between the two eyes);\n* Willing to be randomized;\n* Best corrected visual acuity of 20/25 or better in each eye;\n* Willing to wear eyeglasses full-time;\n* Willing to return for follow-up visits\n\nExclusion Criteria:\n\n* Previous wear of glasses or contacts for farsightedness/hyperopia;\n* Eye disease that affects visual function;\n* Amblyopia (lazy eye);\n* Strabismus (eye turn);\n* History of strabismus surgery;\n* Chronic use of any of the following medications:\n\n * Antianxiety agents (Librium, Valium)\n * Antiarrythmic agents (Cifenline, Cibenzoline)\n * Anticholinergics (Motion sickness patch - scopolamine)\n * Bladder spasmolytic (Propiverine)\n * Chloroquine\n * Phenothiazines (Compazine, Mellaril, Thorazine)\n * Tricyclic antidepressants (Elavil, Nortriptyline, Tofranil)'}, 'identificationModule': {'nctId': 'NCT00472212', 'acronym': 'CHICS', 'briefTitle': 'Correction of Farsightedness in Children Study', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Correction of Hyperopia in Children Study', 'orgStudyIdInfo': {'id': '2001H0401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spectacles', 'description': 'Spectacles with hyperopic lenses', 'interventionNames': ['Device: Spectacles']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Spectacles with placebo lenses', 'interventionNames': ['Device: Control']}], 'interventions': [{'name': 'Spectacles', 'type': 'DEVICE', 'description': 'Hyperopic spectacle lenses', 'armGroupLabels': ['Spectacles']}, {'name': 'Control', 'type': 'DEVICE', 'description': 'Plano (no power, control) spectacle lenses', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60616', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois College of Optometry/Illinois Eye Institute', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '10036', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY College of Optometry/University Optometric Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southern College of Optometry', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Marjean Kulp, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Academy of Optometry', 'class': 'OTHER'}, {'name': 'Transitions', 'class': 'INDUSTRY'}, {'name': 'Ohio Lions Eye Research Foundation', 'class': 'OTHER'}, {'name': 'College of Optometrists in Vision Development', 'class': 'OTHER'}, {'name': 'SUNY Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marjean Kulp', 'investigatorAffiliation': 'Ohio State University'}}}}