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Recruiting NCT07318961

Autologous Tenon's Capsule Graft for Refractory Macular Holes

Trial Parameters

Condition Macular Hole Surgery
Sponsor Benha University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-14
Completion 2026-06-01
Interventions
Autologous Tenon's Capsule Graft Placement

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

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