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A piece of your own cornea might patch a thinning one — a trial puts it to the test

NCT ID NCT04591587

Disease control Sponsor: Dr. Faruk Semiz 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial tests whether a corneal lenticule — a thin disc of tissue taken from a donor eye during a type of laser surgery — can be implanted into the cornea of people with progressive keratoconus, a condition where the cornea thins and bulges outward. The goal is to increase corneal thickness and improve vision. Forty participants with progressive keratoconus will receive the implant, and researchers will measure changes in corneal thickness, visual acuity, and astigmatism.

What this could mean

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

Active substance
a corneal lenticule implant obtained from RELEX SMILE surgery
What this could lead to
If it works, this could offer a new way to strengthen the cornea and improve vision in people with keratoconus, potentially delaying or avoiding a corneal transplant.
What could go wrong
This is a small, early-stage trial with 40 participants. The procedure involves surgery and carries risks such as infection, graft rejection, or scarring. Long-term safety and effectiveness are not yet known.

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 40 people

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

Started

Jan 2018

Expected to finish

Dec 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

20 to 40 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 clinically diagnosed with progressive keratoconus Exclusion Criteria: * Active anterior segment pathologic features, Corneal thickness over 420, Previous corneal or anterior segment surgery

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Conditions

The condition(s) this trial relates to.

keratoconus

As listed by the trial registrant

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

Keratoconus

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Eye Hospital Pristina

    Pristina, 10000, Kosovo

More trials for these conditions

Other studies related to the condition(s) this trial covers.