Autologous Tenon's capsule graft for stubborn macular holes
Visual and Anatomical Outcomes of Autologous Tenon's Capsule Graft for Refractory Macular Holes
NA · Benha University · NCT07318961
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Benha University (other) |
| Locations | 1 site (Banhā, Benha) |
| Trial ID | NCT07318961 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Banhā, Benha
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Macular Hole Surgery, Autologous Tenon's Capsule Graft, Macular Hole