A slice of donor cornea may patch thinning eyes — a trial puts it to the test
NCT ID NCT04848740
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests whether implanting a thin layer of fresh donor corneal tissue — complete with living cells — can thicken the cornea and improve vision in people with progressive corneal disease. Using a femtosecond laser, surgeons create a pocket in the patient's cornea and insert the lenticule. The study will measure changes in corneal thickness and transparency.
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 human corneal lenticule (stromal tissue with stem cells and live keratocytes) implanted into the cornea using the ReLex-Smile femtosecond laser technique
- What this could lead to
- If it works, this could offer a way to restore corneal thickness and transparency in people with progressive corneal disease, potentially improving vision without a full corneal transplant.
- What could go wrong
- This is an early-stage, non-randomized trial with no control group. Risks include infection, graft rejection, or failure to improve vision. 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
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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
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2018
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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20 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * progressive corneal disease with thin corneal thickness * corneal low transparenc * low visual acuity Exclusion Criteria: * active anterior segment pathology * previous corneal or anterior segment surgery * other infection etc.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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.
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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
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Eye Hospital Pristina
Pristina, 10000, Kosovo