NCT07318961 Autologous Tenon's Capsule Graft for Refractory Macular Holes
| NCT ID | NCT07318961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Benha University |
| Condition | Macular Hole Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-14 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12-14 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older * Refractory full-thickness macular hole defined as: * Chronic macular hole \>400 µm, or * Persistent macular hole following prior vitrectomy with ILM peeling and gas tamponade * Clear ocular media and adequate fixation for OCT imaging * Ability to provide informed consent Exclusion Criteria: * Active ocular infection or inflammation * Advanced glaucoma or optic neuropathy * History of intraocular tumors * Severe proliferative vitreoretinopathy * Significant systemic diseases likely to affect visual recovery
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07318961 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Macular Hole Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07318961 currently recruiting?
Yes, NCT07318961 is actively recruiting participants. Contact the research team at ehab.saad@fmed.bu.edu.eg for enrollment information.
Where is the NCT07318961 trial being conducted?
This trial is being conducted at Banhā, Egypt.
Who is sponsoring the NCT07318961 clinical trial?
NCT07318961 is sponsored by Benha University. The trial plans to enroll 20 participants.