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Donated corneal tissue eyed as fix for Post-LASIK farsightedness

NCT ID NCT04793893

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Many people who have LASIK still need glasses for leftover farsightedness. Researchers are testing whether implanting a thin piece of donated corneal tissue, shaped by ReLex Smile surgery, can improve vision. The trial enrolls 60 young adults with residual farsightedness after LASIK. Doctors place the lenticule into the cornea to reshape it and reduce the need for corrective lenses.

What this could mean

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

Active substance
implantation of fresh human corneal lenticules using ReLex Smile surgery
What this could lead to
If it works, this could offer a less invasive way to correct residual farsightedness after LASIK, avoiding the risks of lens replacement surgery.
What could go wrong
This is an early study with 60 participants. The implanted tissue may not integrate well, could be rejected, or may not produce lasting vision improvement. Long-term effects are unknown.

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 60 people

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

Started

Jan 2017

Expected to finish

Nov 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 45 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: * residual hypermetropic refraction, * low visual acuity Exclusion Criteria: * active anterior segment pathology, * glaucoma, * retinae detachment,

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Conditions

The condition(s) this trial relates to.

refractive error

As listed by the trial registrant

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

Refractive errors

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

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