Closure of a macular hole with Tenon capsule graft versus ILM flap
Official title: Comparison Between Outcomes of Closure of Idiopathic Macular Hole Using Autologus Tenon Capsule Graft and Internal Limiting Membrane Flap Techniques (Pilot Study)
Run by Ain Shams University · NCT07633457 · Data updated 2026-11-12
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.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Abbassia) |
| Status | Recruiting |
| Started | November 9, 2025 |
| Main results expected | December 1, 2027 |
| Study ends | January 1, 2028 |
| Registry record updated | June 8, 2026 |
| Trial ID | NCT07633457 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with idiopathic full-thickness macular holes measuring 400 micrometers or larger, suitable for pars plana vitrectomy with ILM peeling.
✕Probably not a fit
Patients with media opacities or other retinal conditions limiting imaging, or those who have intraoperative complications, may not benefit from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients with idiopathic full-thickness macular holes of at least 400 microns will undergo vitrectomy and ILM peeling, then be treated with either a Tenon capsule graft or an inverted ILM flap. The study compares functional visual outcomes, the rate of hole closure, and macular perfusion changes using OCT and OCTA after surgery. It is a small, early-phase pilot to see which technique provides better anatomical and visual results in larger holes. Outcomes of interest include anatomical closure, visual acuity, and retinal vascular changes.
Why it matters
Potential benefit: If successful, the Tenon capsule graft could offer an effective autologous option for closing larger macular holes and potentially improve visual outcomes.
How similar studies have gone: Other approaches using autologous or alternative scaffolds for macular hole closure have shown variable success, with ILM flap techniques increasingly used for large holes; this specific Tenon graft comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with idiopathic full-thickness macular hole * ≥400 µm in horizontal diameter Exclusion Criteria: * Media opacity preventing adequate OCT/OCTA imaging * Other retinal vascular pathology as retinal vascular occlusion * Intraoperative complications * Signal noise ratio using OCTA \<6\\10 * Poor fixation of the patient
Where it's running
-
Ain Shams University
Cairo, Abbassia, Egypt Recruiting
Study contacts
- Study coordinator: Khaled Nehad Elsherief
- Email: khalednehad0100209@med.asu.edu.eg
- Phone: 0201225602369
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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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Primary versus secondary ILM peeling for rhegmatogenous retinal detachment
This trial will test whether peeling the internal limiting membrane (ILM) during the first vitrectomy or waiting until silicone oil removal leads to better vision and fewer complications for people with uncomplicated rhegmatogenous retinal detachment.
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Autologous Tenon's capsule graft for stubborn macular holes
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.
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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.