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Can a donor corneal lenticule patch up a thinning cornea?

NCT ID NCT04594512

Disease control Sponsor: Eye Hospital Pristina Kosovo 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 case report tests whether implanting a fresh corneal lenticule from a myopic donor, along with autologous serum drops, can safely thicken the cornea and improve vision in a person with advanced keratoconus. The procedure uses a femtosecond laser to place the graft. The goal is to see if this approach can increase central corneal thickness and reduce steepness, while the serum drops may aid recovery in patients with mild dry eye.

What this could mean

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

Active substance
a fresh corneal lenticule implant from a myopic donor, plus autologous serum eye drops
What this could lead to
If it works, this approach could offer a new way to thicken the cornea and improve vision in people with advanced keratoconus who have few other options.
What could go wrong
This is a single-patient case report, so results may not apply to others. Risks include graft rejection, infection, or no improvement in vision.

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

1 person

The number who actually took part.

Started

May 2019

Expected to finish

May 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

19 to 20 years

Sex

Female participants only

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: * Be at least 18 years of age, male or female, of any race * Willingness and ability to follow all instructions and comply with schedule for follow-up visits * For females: Must not be pregnant Exclusion Criteria: * Contraindications, sensitivity or known allergy to the use of the test article(s) or their components * If female, pregnant

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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 Keratoconus of right eye Keratoconus, unstable, right eye

Contacts and locations

Locations

  • Eye Hospital Pristina

    Pristina, 10000, Kosovo

More trials for these conditions

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