Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-30 @ 8:16 AM
Study NCT ID:
NCT00376857
Status:
COMPLETED
Last Update Posted:
2006-09-15
First Post:
2006-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'lastUpdateSubmitDate': '2006-09-13', 'studyFirstSubmitDate': '2006-09-13', 'studyFirstSubmitQcDate': '2006-09-13', 'lastUpdatePostDateStruct': {'date': '2006-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main outcome measure was improvement of best-corrected visual acuity (BCVA).'}], 'secondaryOutcomes': [{'measure': 'Other outcome measures included postoperative BCVA, status of Amsler grid test, reduction of macular retinal thickness, residual or recurrent macular epiretinal membrane'}]}, 'conditionsModule': {'keywords': ['Indocyanine green, toxicity, epiretinal membrane, visual field defect'], 'conditions': ['Idiopathic Epiretinal Membrane, Cataract']}, 'referencesModule': {'references': [{'pmid': '17186261', 'type': 'DERIVED', 'citation': 'Hillenkamp J, Saikia P, Herrmann WA, Framme C, Gabel VP, Sachs HG. Surgical removal of idiopathic epiretinal membrane with or without the assistance of indocyanine green: a randomised controlled clinical trial. Graefes Arch Clin Exp Ophthalmol. 2007 Jul;245(7):973-9. doi: 10.1007/s00417-006-0485-1. Epub 2006 Dec 21.'}]}, 'descriptionModule': {'briefSummary': 'It was the aim of the present study to prospectively compare the functional and morphological outcome of idiopathic epiretinal membrane surgery with and without the assistance of Indocyanine green (ICG). The main outcome measure was improvement of best-corrected visual acuity (BCVA). This was treated as an open question and we had no hypothesis which of the two therapies was superior.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with IEM and cataract or posterior chamber intraocular lens pseudophakia complaining of loss of visual acuity and metamorphopsia during the past six months.\n\nExclusion Criteria:\n\n* Other retinal disease, non-idiopathic epiretinal membrane, glaucoma or history of retinal detachment.'}, 'identificationModule': {'nctId': 'NCT00376857', 'briefTitle': 'Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green.', 'organization': {'class': 'OTHER', 'fullName': 'University of Regensburg'}, 'officialTitle': 'Surgical Removal of Idiopathic Epiretinal Membrane With and Without the Assistance of Indocyanine Green: a Randomised Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '03123'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Surgery with and without the aid of Indocyanine Green (ICG)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93042', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Dept. of Ophthalmology, University of Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Jost Hillenkamp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Ophthalmology, University of Regensburg'}, {'name': 'Parykshit Saikia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Ophthalmology, University of Regensburg'}, {'name': 'Helmut G Sachs, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Ophthalmology, University of Regensburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regensburg', 'class': 'OTHER'}}}}