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Can a patch of the Eye's own tissue seal stubborn macular holes?

NCT ID NCT07760259

Disease control Sponsor: Benha University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial is testing whether a piece of the patient's own eye tissue, called Tenon's capsule, can help close large or recurrent macular holes—tears in the center of the retina that can blur or distort vision. During standard vitrectomy surgery, the tissue is harvested and placed over the hole, followed by a silicone oil fill to support healing. The study will follow 50 adults for six months to see if the hole closes and if vision improves, while also checking for any complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Autologous Tenon's capsule autograft (a piece of the patient's own eye tissue) implanted during vitrectomy surgery
What this could lead to
If successful, this could offer a new surgical option for difficult-to-treat macular holes, potentially improving closure rates and vision in patients who have few alternatives.
What could go wrong
This is a small, early-stage trial, and the procedure is complex. The graft may not integrate well, and there are risks of infection, bleeding, or other surgical complications. Results may not generalize to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Jul 2025

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

macular holes retinal perforation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Macular hole surgery Macular holes

Contacts and locations

Locations

  • Benha University

    Banhā, Benha, 13111, Egypt

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