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

Overview

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.

Large, chronic, and recurrent full-thickness macular holes remain challenging to treat despite advances in vitreoretinal surgery. Although pars plana vitrectomy with internal limiting membrane peeling achieves high closure rates in primary macular holes, anatomical success is reduced in very large or recurrent cases. Alternative surgical techniques, including inverted internal limiting membrane flaps, autologous retinal transplantation, and human amniotic membrane grafts, have demonstrated promising results but may be technically demanding or have limited availability. Autologous Tenon's capsule is an easily accessible, biocompatible tissue that may provide an effective scaffold for macular hole closure while avoiding the disadvantages associated with other grafting techniques. This is a prospective, single-center interventional clinical trial conducted at the Department of Ophthalmology, Zagazig University Hospitals. Fifty eligible adult patients with large (\>400 µm), chronic, recurrent, or high-myopic full-thickness macular holes will be enrolled. All participants will undergo standard 23-gauge pars plana vitrectomy. Residual internal limiting membrane will be re-peeled when present, followed by harvesting an autologous Tenon's capsule graft from the superior bulbar conjunctiva. The graft will be trimmed, inserted into the macular hole under perfluorocarbon liquid, and stabilized with 5000-centistoke silicone oil tamponade. Patients will maintain a face-down position for 5 to 7 days after surgery. Participants will be examined on postoperative day 1, at week 1, and at months 1, 3, and 6. Anatomical closure of the macular hole will be assessed using spectral-domain optical coherence tomography, while functional outcomes will be evaluated by best-corrected visual acuity. Additional assessments include graft position and integration on OCT, intraocular pressure, and the occurrence of postoperative complications such as graft displacement, retinal detachment, or endophthalmitis. The primary outcome is macular hole closure at 3 months, and secondary outcomes include best-corrected visual acuity at 1, 3, and 6 months, graft integration, and postoperative complications.