Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT01229657
Status:
COMPLETED
Last Update Posted:
2010-10-28
First Post:
2010-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-27', 'studyFirstSubmitDate': '2010-10-27', 'studyFirstSubmitQcDate': '2010-10-27', 'lastUpdatePostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Reopening of macular hole;', 'Visual acuity;', 'Phacoemulsification cataract surgery;', 'Vitrectomy'], 'conditions': ['Macular Holes']}, 'descriptionModule': {'briefSummary': 'To evaluate the anatomic and visual outcomes in patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up.', 'detailedDescription': "In recent years, peeling of the internal limiting membrane (ILM) has been used as a supplementary treatment to reducing the tangential tractional forces and inducing hole closure in macular hole surgery, and thus the anatomic success rate has increased to over 90%. However, despite these high rates of surgical success, the reopening of initially closed macular holes has also been observed from the first month to several years following surgery. Because about 45% to 95% of phakic patients frequently develop a progressive nuclear sclerosis cataract after macular hole surgery and require combined or subsequent cataract extraction to improve visual acuity, cataract extraction has become a potential factor in causing macular hole reopening, although this is still under debate. The purpose of this study is to describe the long-term anatomic and visual outcomes in patients who had initial anatomic success with macular hole surgery and who had postoperative follow-up of one or more years. All patient's charts were reviewed for age, macular hole stage (using the Gass classification), macular hole duration, epiretinal membrane of macula presence, ILM peeling, preoperative and postoperative visual acuity, rate of macular hole reopening, cataract extraction, and length of follow-up after vitrectomy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with initially closed macular holes after vitreoretinal surgery and with one to seven years of follow-up', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* successful closure of a macular hole after initial vitreoretinal surgery\n* a follow-up of at least one year\n\nExclusion Criteria:\n\n* post-traumatic holes,\n* myopic macular holes,\n* macular holes associated with a rhegmatogenous retinal detachment,\n* eyes with silicone oil tamponade.'}, 'identificationModule': {'nctId': 'NCT01229657', 'briefTitle': 'Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Study of the Anatomic and Visual Outcomes in Patients With Initially Closed Macular Holes After Vitreoretinal Surgery', 'orgStudyIdInfo': {'id': 'SunYat-senU'}, 'secondaryIdInfos': [{'id': '2008B030301306', 'type': 'OTHER_GRANT', 'domain': 'Science and Technology Projects of Guangdong Province'}, {'id': '2007B031302007', 'type': 'OTHER_GRANT', 'domain': 'Science and Technology Projects of Guangdong Province'}]}, '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': 'Shaochong Zhang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Shaochong Zhang', 'oldOrganization': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}}}}