Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-03 @ 3:53 PM
Study NCT ID:
NCT01901406
Status:
COMPLETED
Last Update Posted:
2014-08-12
First Post:
2013-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change of Retinally-Induced Aniseikonia in Patients With Epiretinal Membrane After Vitrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D000839', 'term': 'Aniseikonia'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-11', 'studyFirstSubmitDate': '2013-07-02', 'studyFirstSubmitQcDate': '2013-07-12', 'lastUpdatePostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Stereopsis tested by TNO test (arc of second)', 'timeFrame': 'from Initial screening day before surgey to postoperative 6 months', 'description': 'Stereopsis is normal binocular vision. Its presence or absence is an important indicator of the state of binocularity. The TNO test is graded to provide retinal disparities ranging from 15 to 480 second of arc.'}, {'measure': 'Titmus test (arc of second)', 'timeFrame': 'from Initial screening day before surgey to postoperative 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epiretinal membrane, stereopsis, aniseikonia'], 'conditions': ['Epiretinal Membranectomy']}, 'descriptionModule': {'briefSummary': 'Epiretinal membrane is common disease, affecting 5\\~10 % incidence over 60 years old population. It reduce visual acuity, cause metamorphopsia. In the past, vitrectomy and epiretinal membranectomy was indicated in patients with visual acuity less than 20/40, but nowadays with technical improvement and surgical instrument renovation, it seems to have been changed the surgical indication. Therefore, we plan to evaluate the changes of binocular visual acuity, aniseikonia in patients with epiretinal membrane.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with epiretinal membrane who had metamorphopsia or had imparied vision, therefore planned to undergo vitrectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic epiretinal membrane who had impaired vision or metamorphopsia, want to undergo vitrectomy\n* Age more than 20 years and less than 90 years old\n\nExclusion Criteria:\n\n* secondary epiretinal membrane due to retinal surgery,\n* impaired visual acuity less than 20/40 in the normal eye(Snellen chart) due to severe cataract\n* glaucoma patients\n* complication during vitrectomy (ex. Retinal tear, silicone oil injection, …)\n* other retinal disease except epiretinal membrane\n* other ocular surgery history within 3 months\n* intellectual problems or illiterate whom could not obtained informed consent'}, 'identificationModule': {'nctId': 'NCT01901406', 'briefTitle': 'Change of Retinally-Induced Aniseikonia in Patients With Epiretinal Membrane After Vitrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '3-2013-0094'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ERM', 'description': 'idiopathic epiretinal membrane patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Institute of Vision Research, Department of Ophthalmology, Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}