Autologous Tenon's Capsule Autograft for Large and Recurrent Full-Thickness Macular Holes

NCT07760259 | Completed

• 1 other identifier: ZU-OPH-ATCG-MH-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective interventional clinical trial aims to evaluate the anatomical and functional outcomes of autologous Tenon's capsule autograft in the surgical management of large and recurrent full-thickness macular holes. Patients with large (\>400 µm), chronic, recurrent, or highly myopic macular holes will undergo 23-gauge pars plana vitrectomy with placement of an autologous Tenon's capsule graft into the macular hole followed by silicone oil tamponade. The primary outcome is anatomical macular hole closure confirmed by spectral-domain optical coherence tomography (SD-OCT). Secondary outcomes include best-corrected visual acuity, graft integration, and postoperative complications during a 6-month follow-up period.

Conditions

Macular Holes; Macular Hole Surgery

Keywords

Large macular hole; Autologous Tenon's capsule graft; Vitrectomy; Chronic macular hole

Outcome Measures

Primary Outcomes (1)

• Macular Hole Closure Rate

  Anatomical closure of the full-thickness macular hole confirmed by spectral-domain optical coherence tomography (SD-OCT). Successful closure is defined as complete approximation of the neurosensory retina over the fovea without a persistent full-thickness defect.

  3 months after surgery

Secondary Outcomes (1)

• Best-Corrected Visual Acuity (BCVA)

  1 month, 3 months, and 6 months after surgery

Study Arms (1)

Autologous Tenon's Capsule Autograft

EXPERIMENTAL

Participants with large, chronic, recurrent, or high-myopic full-thickness macular holes will undergo 23-gauge pars plana vitrectomy with harvesting and implantation of an autologous Tenon's capsule graft into the macular hole under perfluorocarbon liquid, followed by 5000-centistoke silicone oil tamponade. Participants will be followed for 6 months to assess anatomical closure, visual outcomes, graft integration, and postoperative complications.

Procedure: Autologous Tenon's Capsule Autograft

Interventions

Autologous Tenon's Capsule Autograft PROCEDURE

Participants undergo standard 23-gauge pars plana vitrectomy for large or recurrent full-thickness macular holes. An autologous Tenon's capsule graft is harvested from the superior bulbar conjunctiva, trimmed to the appropriate size, and implanted into the macular hole under perfluorocarbon liquid. The procedure is completed with 5000-centistoke silicone oil tamponade. Patients are instructed to maintain face-down positioning for 5 to 7 days after surgery and are followed for 6 months to evaluate anatomical closure, visual outcomes, graft integration, and postoperative complications.

Autologous Tenon's Capsule Autograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older.
• Large full-thickness macular hole (minimum diameter \>400 µm on optical coherence tomography).
• Chronic macular hole (duration \>6 months).
• Recurrent or persistent full-thickness macular hole following previous vitrectomy with or without internal limiting membrane peeling.
• High-myopic full-thickness macular hole (axial length \>26 mm) without active foveoschisis or retinal detachment.
• No active ocular infection or uncontrolled intraocular inflammation.
• Able and willing to comply with postoperative face-down positioning and scheduled follow-up visits.
• Provided written informed consent.

You may not qualify if:

• Macular hole associated with rhegmatogenous, tractional, exudative, or combined retinal detachment.
• Significant ocular comorbidities that could affect visual outcomes (e.g., advanced glaucoma, proliferative diabetic retinopathy, or severe uveitis).
• Active intraocular infection or inflammation.
• Extensive macular atrophy or scarring (e.g., end-stage myopic degeneration).
• Unhealthy Tenon's capsule or severe conjunctival scarring preventing adequate graft harvest.
• Systemic conditions that preclude vitreoretinal surgery or impair wound healing, including uncontrolled diabetes mellitus or bleeding disorders.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13111, Egypt

Location

MeSH Terms

Conditions

Retinal Perforations

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology

Model Details: All enrolled participants will undergo 23-gauge pars plana vitrectomy with placement of an autologous Tenon's capsule autograft for the treatment of large or recurrent full-thickness macular holes followed by silicone oil tamponade. Participants will be followed for 6 months to evaluate anatomical and functional outcomes.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start: July 5, 2025
• Primary Completion: April 3, 2026
• Study Completion: May 15, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

EG (1)