Autologous Tenon's capsule graft for stubborn macular holes
Official title: Visual and Anatomical Outcomes of Autologous Tenon's Capsule Graft for Refractory Macular Holes
Run by Benha University · NCT07318961 · Data updated 2026-11-12
This study will try using a patient's own Tenon's capsule tissue to close stubborn full-thickness macular holes and follow vision and retinal imaging for three months.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banhā, Benha) |
| Status | Recruiting |
| Started | December 14, 2025 |
| Main results expected | December 1, 2026 |
| Study ends | January 3, 2027 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07318961 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with refractory full-thickness macular holes—either chronic large holes >400 µm or persistent holes after prior vitrectomy with ILM peel and gas tamponade—with clear media and adequate fixation who can provide informed consent.
✕Probably not a fit
Patients with active ocular infection or inflammation, advanced glaucoma or optic neuropathy, severe proliferative vitreoretinopathy, a history of intraocular tumors, or systemic diseases likely to limit visual recovery are unlikely to benefit from this procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective single-arm interventional study enrolling adults with refractory full-thickness macular holes, including chronic large holes (>400 µm) or holes that persist after prior vitrectomy with ILM peeling and gas. All participants will undergo pars plana vitrectomy with placement of a trimmed autologous Tenon's capsule graft into the macular defect followed by silicone oil tamponade. Anatomical closure will be determined using spectral-domain OCT and functional outcome will be measured by best-corrected visual acuity at predefined postoperative visits over a three-month follow-up. The study aims to quantify closure rates and short-term visual changes after this surgical technique.
Why it matters
Potential benefit: If successful, this approach could increase anatomical closure rates and improve vision in patients with macular holes that have failed conventional surgery.
How similar studies have gone: Other autologous grafting techniques (e.g., ILM flaps, lens capsule, autologous retinal transplant) have shown promising closure rates in small series, while Tenon's capsule grafting is a more recent approach with encouraging early reports.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
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Benha University
Banhā, Benha, Egypt Recruiting
Study contacts
- Study coordinator: Ehab Mohamed Elsayed Saad Saad, lecturer
- Email: ehab.saad@fmed.bu.edu.eg
- Phone: 00201008418667
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Closure of a macular hole with Tenon capsule graft versus ILM flap
This pilot study tests whether using a piece of the patient’s Tenon capsule can help close a macular hole as well as or better than the standard ILM flap technique.
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Repairing full-thickness macular holes without using gas (no endotamponade)
This trial sees if an internal limiting membrane (ILM) flap technique that omits gas can close full-thickness macular holes in adults as safely and effectively as the usual vitrectomy with gas tamponade.
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Treatment options for full thickness macular holes
This study is testing two different surgery methods for treating full thickness macular holes to see which one helps people see better with fewer problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.