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Autologous Tenon's Capsule Graft for Refractory Macular Holes

Autologous Tenon's Capsule Graft for Refractory Macular Holes

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

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.

This 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.

Eligibility

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

Study details
    Macular Hole Surgery

NCT07318961

Benha University

1 February 2026

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