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RECRUITING Not applicable ClinicalTrials.gov

Autologous Tenon's Capsule Graft for Refractory Macular Holes

Sponsor: Benha University • ClinicalTrials.gov ID: NCT07318961

Registry updated: 2026-09-30
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Description

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.

Interventions

  • Autologous Tenon's Capsule Graft Placement (Procedure)
    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.

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

Conditions

Macular Hole Surgery

Locations

  • Benha University — Banhā, Benha, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record