Autologous Tenon's Capsule Autograft for Large and Recurrent Full-Thickness Macular Holes (NCT07760259) | Clinical Trial Compass
CompletedNot Applicable
Autologous Tenon's Capsule Autograft for Large and Recurrent Full-Thickness Macular Holes
Egypt50 participantsStarted 2025-07-05
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older.
* Large full-thickness macular hole (minimum diameter \>400 µm on optical coherence tomography).
* Chronic macular hole (duration \>6 months).
* Recurrent or persistent full-thickness macular hole following previous vitrectomy with or without internal limiting membrane peeling.
* High-myopic full-thickness macular hole (axial length \>26 mm) without active foveoschisis or retinal detachment.
* No active ocular infection or uncontrolled intraocular inflammation.
* Able and willing to comply with postoperative face-down positioning and scheduled follow-up visits.
* Provided written informed consent.
Exclusion Criteria:
* Macular hole associated with rhegmatogenous, tractional, exudative, or combined retinal detachment.
* Significant ocular comorbidities that could affect visual outcomes (e.g., advanced glaucoma, proliferative diabetic retinopathy, or severe uveitis).
* Active intraocular infection or inflammation.
* Extensive macular atrophy or scarring (e.g., end-stage myopic degeneration).
* Unhealthy Tenon's capsule or severe conjunctival scarring preventing adequate graft harvest.
* Systemic conditions that preclude vitreoretinal surgery or impair wound healing, including uncontrolled diabetes mellitus or bleeding disorders.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.