An interventional study of Autologous Tenon's Capsule Autograft in Macular Holes and Macular Hole Surgery, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 94 interventional studies indexed under Retinal Perforations.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: 3 months after surgery
Best-Corrected Visual Acuity (BCVA)
Change in best-corrected visual acuity measured in logarithm of the minimum angle of resolution (logMAR) from baseline to postoperative follow-up visits.
Time frame: 1 month, 3 months, and 6 months after surgery
Ran from Jul 2025 to primary completion in Apr 2026, 8 months.
Of 45 non-industry interventional studies with no phase under Retinal Perforations, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's 8 months is below that.
Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 12 and three quarters within 31.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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