Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-03-05 @ 7:34 PM
Study NCT ID:
NCT02761850
Status:
COMPLETED
Last Update Posted:
2016-05-05
First Post:
2016-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Developmental Profile of Ocular Refraction in Patients With Congenital Cataract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1164}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-04', 'studyFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The refraction status (presented as spherical equivalent, SE)', 'timeFrame': 'Baseline', 'description': 'Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '26339020', 'type': 'BACKGROUND', 'citation': 'Lin H, Long E, Chen W, Liu Y. Documenting rare disease data in China. Science. 2015 Sep 4;349(6252):1064. doi: 10.1126/science.349.6252.1064-b. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.gzzoc.com/', 'label': 'Home page of Zhongshan Ophthalmic Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of prospective cohort study is to describe the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC.', 'detailedDescription': 'The refractive status is crucial to visual function and may change throughout life. For patients with congenital cataract (CC), the developmental profile of refraction is complicated due to the potential influences of diverse clinical manifestations and various treatments, and has not yet been fully characterized.\n\nThe investigator described the developmental profile of refraction change in a large cohort of Chinese CC patients. The decisive factors to the range of myopic shift in unilateral CC appeared to be different from that in bilateral CC, indicating dramatic differences in the etiopathogenesis and refractive prognosis between bilateral and unilateral CC. The refraction data from CC patients provided in the study are of clinical significance to the guidelines for CC treatment, especially for IOL calculation concerning the laterality of CC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CC were enrolled from the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH). The study involved 1,164 participants (6,585 persontimes) enrolled from Jan 2010 to Oct 2015. Cataract removal and/or intraocular lens (IOL) implantation were conducted by two experienced cataract surgeons for participants.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with uncomplicated surgeries\n* Children with unilateral/bilateral cataract\n\nExclusion Criteria:\n\n* Corneal diseases\n* Lens luxation\n* Glaucoma\n* Retinal diseases\n* Nystagmus and nanophthalmos'}, 'identificationModule': {'nctId': 'NCT02761850', 'briefTitle': 'Developmental Profile of Ocular Refraction in Patients With Congenital Cataract', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Developmental Profile of Ocular Refraction in Patients With Congenital Cataract: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'CCPMOH2016-China-2'}}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Haotian Lin, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, {'name': 'Yizhi Liu, M.D., Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, {'name': 'Weirong Chen, M.D., Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center', 'investigatorFullName': 'Haotian Lin', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}