Autologous Tenon's Capsule Graft for Refractory Macular Holes

NCT07318961 | Recruiting

• 1 other identifier: Macular hole rapair
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Macular Hole Surgery

Keywords

Autologous Tenon's Capsule Graft; Macular Hole

Outcome Measures

Primary Outcomes (1)

• Macular hole anatomical closure

  Complete closure of the macular hole as confirmed by spectral-domain OCT

  3 months postoperatively

Secondary Outcomes (1)

• Change in Best-Corrected Visual Acuity (logMAR)

  Baseline (preoperative), 1 month postoperatively, and 3 months postoperatively

Study Arms (1)

Autologous Tenon's Capsule Graft

OTHER

Procedure

Procedure: Autologous Tenon's Capsule Graft Placement

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.

Autologous Tenon's Capsule Graft

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Benha, 13111, Egypt

RECRUITING

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Central Study Contacts

Ehab Mohamed Elsayed Saad Saad, lecturer

CONTACT

00201008418667; ehab.saad@fmed.bu.edu.eg

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

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 6, 2026
• Study Start: December 14, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 3, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

EG (1)