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COMPLETED
NCT07760259
NA

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

Sponsor: Benha University

View on ClinicalTrials.gov

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.

Official title: Outcomes of Autologous Tenon's Capsule Autograft for Large and Recurrent Full-Thickness Macular Holes: A Prospective Interventional Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-07-05

Completion Date

2026-05-15

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

PROCEDURE

Autologous Tenon's Capsule Autograft

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.

Locations (1)

Benha University

Banhā, Benha, Egypt