Autologous Tenon's Capsule Graft for Refractory Macular Holes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-14

Study Completion Date

2026-06-03

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Macular Hole Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous Tenon's Capsule Graft

Procedure

Group Type OTHER

Autologous Tenon's Capsule Graft Placement

Intervention Type 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.

Interventions

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Autologous Tenon's Capsule Graft Placement

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No