Autologous Tenon's Capsule Graft for Refractory Macular Holes (ATCG-RMH)

Benha University

Status: Enrolling

Conditions: Macular Hole Surgery

Treatments: Procedure: Autologous Tenon's Capsule Graft Placement

Study type: Interventional

Funder types: Other

Identifiers

NCT07318961

Macular hole rapair

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Autologous Tenon's Capsule Graft

Other group

Description:

Procedure

Treatment:

Procedure: Autologous Tenon's Capsule Graft Placement