Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:28 AM
Study NCT ID:
NCT06194760
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2023-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014821', 'term': 'Vitrectomy'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-23', 'studyFirstSubmitDate': '2023-12-23', 'studyFirstSubmitQcDate': '2023-12-23', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Closure of macular hole', 'timeFrame': '6 months post operative', 'description': 'It is a subjective outcome measured by Optical coherence tomography and by clinical slit lamb examination'}, {'measure': 'BCVA', 'timeFrame': 'baseline', 'description': 'It is a measure of the visual acuity, which will be measured by LogMar'}, {'measure': 'BCVA', 'timeFrame': '6 months postoperative', 'description': 'It is a measure of the visual acuity, which will be measured by LogMar'}, {'measure': 'BCVA', 'timeFrame': '12 months postoperative', 'description': 'It is a measure of the visual acuity, which will be measured by LogMar'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinal Detachment']}, 'descriptionModule': {'briefSummary': 'Retinal detachment (RD) resulting from the macular hole (MH), also known as MH-induced RD (MHRD), most commonly occurs in eyes with high myopia and results in irreversible visual disorders. Although ILM peeling for MHRD reportedly achieves a high retinal reattachment rate that ranges from 70% to 100%, the MH closure rate is relatively low, ranging from 10% to 70%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with high myopia (a spherical equivalent refractive error of at least -6.0 diopters (D) and an axial length of at least 26.5 mm).\n* Macular hole and only posterior retinal detachment\n\nExclusion Criteria:\n\n* Other causes of RD\n* Patients with a history of trauma, choroidal neovascularization, coexistence with a peripheral retinal break or proliferative vitreoretinopathy\n* History of any vitreoretinal surgery prior to MHRD and less than 36 months of follow-up after the surgery'}, 'identificationModule': {'nctId': 'NCT06194760', 'briefTitle': 'Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment', 'orgStudyIdInfo': {'id': 'Vitrectomy with ILM peeling'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'myopic eyes with macular hole and only posterior retinal detachment', 'interventionNames': ['Procedure: Vitrectomy with ILM peeling']}], 'interventions': [{'name': 'Vitrectomy with ILM peeling', 'type': 'PROCEDURE', 'description': 'Vitrectomy with traditional internal limiting membrane (ILM) peeling technique is regarded as the gold standard treatment for MH; it works by completely relieving of the traction of the macula and increasing the flexibility of the retina', 'armGroupLabels': ['myopic eyes with macular hole and only posterior retinal detachment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34517', 'city': 'Damietta', 'state': 'New Damietta', 'country': 'Egypt', 'facility': 'Ehab tharwat', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ehab Tharwat', 'investigatorAffiliation': 'Al-Azhar University'}}}}