Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 5:48 PM
Study NCT ID:
NCT07318961
Status:
RECRUITING
Last Update Posted:
2026-01-06
First Post:
2025-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Tenon's Capsule Graft for Refractory Macular Holes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-21', 'studyFirstSubmitDate': '2025-12-21', 'studyFirstSubmitQcDate': '2025-12-21', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macular hole anatomical closure', 'timeFrame': '3 months postoperatively', 'description': 'Complete closure of the macular hole as confirmed by spectral-domain OCT'}], 'secondaryOutcomes': [{'measure': 'Change in Best-Corrected Visual Acuity (logMAR)', 'timeFrame': 'Baseline (preoperative), 1 month postoperatively, and 3 months postoperatively', 'description': "Change in best-corrected visual acuity (BCVA), measured in logMAR units, comparing postoperative values with baseline (preoperative) BCVA to assess functional visual improvement following autologous Tenon's capsule graft surgery."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Autologous Tenon's Capsule Graft", 'Macular Hole'], 'conditions': ['Macular Hole Surgery']}, 'descriptionModule': {'briefSummary': "This prospective interventional study evaluates the anatomical and functional outcomes of autologous Tenon's capsule grafting in patients with refractory full-thickness macular holes. Eligible patients include those with chronic large macular holes (\\>400 µm) or persistent holes following prior pars plana vitrectomy with internal limiting membrane peeling and gas tamponade. Anatomical closure will be assessed using spectral-domain optical coherence tomography, and functional outcomes will be evaluated by best-corrected visual acuity over a 3-month follow-up period.", 'detailedDescription': "Refractory full-thickness macular holes represent a significant surgical challenge, with reduced closure rates following conventional techniques, particularly in large or chronic defects. Autologous tissue grafting has emerged as an alternative strategy to provide a biological scaffold for retinal tissue bridging and gliosis. Tenon's capsule is a readily accessible autologous fibrovascular tissue that can be harvested intraoperatively with minimal morbidity.\n\nThis prospective single-arm clinical study aims to assess the anatomical closure rate and visual outcomes following autologous Tenon's capsule graft placement in refractory macular holes. All patients will undergo standard pars plana vitrectomy, placement of a trimmed Tenon's graft into the macular hole, and silicone oil tamponade. Outcomes will be evaluated using standardized visual acuity testing and spectral-domain OCT imaging at predefined postoperative intervals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Refractory full-thickness macular hole defined as:\n* Chronic macular hole \\>400 µm, or\n* Persistent macular hole following prior vitrectomy with ILM peeling and gas tamponade\n* Clear ocular media and adequate fixation for OCT imaging\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Active ocular infection or inflammation\n* Advanced glaucoma or optic neuropathy\n* History of intraocular tumors\n* Severe proliferative vitreoretinopathy\n* Significant systemic diseases likely to affect visual recovery'}, 'identificationModule': {'nctId': 'NCT07318961', 'acronym': 'ATCG-RMH', 'briefTitle': "Autologous Tenon's Capsule Graft for Refractory Macular Holes", 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': "Visual and Anatomical Outcomes of Autologous Tenon's Capsule Graft for Refractory Macular Holes", 'orgStudyIdInfo': {'id': 'Macular hole rapair'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "Autologous Tenon's Capsule Graft", 'description': 'Procedure', 'interventionNames': ["Procedure: Autologous Tenon's Capsule Graft Placement"]}], 'interventions': [{'name': "Autologous Tenon's Capsule Graft Placement", 'type': 'PROCEDURE', 'description': "Participants will undergo 23-gauge pars plana vitrectomy. Autologous Tenon's capsule tissue will be harvested through conjunctival peritomy, trimmed appropriately, and placed into the macular hole using intraocular forceps. Perfluorocarbon liquid may be used for graft stabilization, followed by silicone oil tamponade. Silicone oil removal is planned after 8-12 weeks.", 'armGroupLabels': ["Autologous Tenon's Capsule Graft"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '13111', 'city': 'Banhā', 'state': 'Benha', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Ismael Ramadan, assistant lecturer', 'role': 'CONTACT', 'email': 'ehab.saad@fmed.bu.edu.eg', 'phone': '00201090506166'}], 'facility': 'Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Ehab Mohamed Elsayed Saad Saad, lecturer', 'role': 'CONTACT', 'email': 'ehab.saad@fmed.bu.edu.eg', 'phone': '00201008418667'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Ehab Mohamed Elsayed Mohamed Saad', 'investigatorAffiliation': 'Benha University'}}}}