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Scientists test Lab-Made corneal implants to restore sight

NCT ID NCT04319848

Disease control Sponsor: Singapore Eye Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial tests a new type of corneal graft made from lab-grown human cells. It is for people with mild to moderate corneal damage from conditions like Fuchs' dystrophy or after eye surgery. The goal is to see if the graft is safe and can improve vision. 30 participants are being enrolled in Singapore.

What this could mean

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

Active substance
tissue-engineered corneal endothelial graft
What this could lead to
If successful, this could provide a new treatment option for corneal damage using lab-grown cells, potentially reducing the need for donor corneas.
What could go wrong
This is an early Phase 1 trial with only 30 participants, so safety and effectiveness are not yet proven. The graft may not work as expected or could cause complications.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

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

Started

Dec 2017

Expected to finish

Jun 2028

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

21 to 80 years

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: Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from a variety of conditions including: * Fuchs' endothelial dystrophy * Post-surgical corneal decompensation (irreversible) - all forms of pseudophakic or aphakic bullous keratopathy Exclusion Criteria: * Severe forms or late stage presentation of corneal decompensation with severe corneal stromal scarring, unsuitable for TE-EK surgery as opposed to penetrating keratoplasty * Patients with complex anterior segment complications precluding a successful TE-EK procedure * Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation * Post-laser iridotomy or glaucoma related corneal decompensation * Patients not keen to participate in the clinical trial * Patients who are below 21 years of age or above 80 years of age * Patients who are pregnant * Patients who are cognitively impaired * Patients who are prisoners * Patients who are allergic to antibiotics

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Conditions

The condition(s) this trial relates to.

bullous keratopathy corneal edema Fuchs' endothelial dystrophy

As listed by the trial registrant

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

Bullous keratopathy Fuchs' endothelial dystrophy Mild to moderate corneal endothelial decompensation Post-surgical corneal decompensation (irreversible)

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

  • Singapore Eye Research Institute

    RECRUITING

    Singapore, Singapore

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