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Amniotic gel could patch macular holes without complex surgery

NCT ID NCT06433284

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study tests a new gel made from donated amniotic membrane to treat large macular holes, a condition that blurs central vision. The gel is injected into the eye during surgery to help close the hole. Researchers will compare this method to the standard flap technique in 26 adults. The goal is to see if the gel works as well or better, with fewer complications.

What this could mean

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

Active substance
decellularized human amniotic membrane hydrogel
What this could lead to
If it works, this could offer a safer, easier way to close large macular holes and improve vision without the need for complex flap surgery.
What could go wrong
This is a small, early-stage trial with only 26 participants. The hydrogel is new for eye surgery, so its safety and effectiveness are not yet proven. There may be risks like infection or inflammation.

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

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

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: Age ≥18 years Idiopathic full-thickness macular hole with minimum diameter \>400 µm confirmed on SD-OCT Willing and able to provide written informed consent and comply with 6-month follow-up schedule Exclusion Criteria: Full-thickness macular hole with minimum diameter \>1,500 µm Traumatic macular holes Myopic macular holes (axial length \>26.5 mm or refractive error less than -8.0 diopters) Co-existing ocular pathologies independently affecting visual acuity (glaucoma with visual field loss, advanced age-related macular degeneration, diabetic macular edema, or epiretinal membrane requiring surgery) Active intraocular inflammation or infection Previous vitreoretinal surgery Medical unfitness for local anesthesia surgery as determined by the anesthesiologist Inability to maintain prone positioning postoperatively

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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 holes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Jakkrit Juhong

    RECRUITING

    Nakhon Si Thammarat, Thasala, 80160, Thailand

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