Can a donor lens implant restore clarity to clouded corneas?
NCT ID NCT04642729
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial investigates whether implanting a fresh corneal lenticule — a thin layer of donor cornea taken from myopic patients — can improve transparency and vision in people with macular corneal dystrophy, a condition that clouds the cornea. Using a femtosecond laser, surgeons remove damaged tissue and replace it with a healthy lenticule carrying live keratocytes. The study will measure changes in corneal clarity and visual acuity over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fresh corneal lenticule implantation using Relex-Smile surgery
- What this could lead to
- If it works, this could offer a new way to restore corneal clarity and vision in people with macular corneal dystrophy, potentially reducing the need for full corneal transplants.
- What could go wrong
- This is a very small, early-stage trial with only 15 participants. The procedure is experimental, and risks include infection, graft rejection, 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
-
About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2019
- Expected to finish
-
Jun 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 55 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 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: * indications for penetrating keratoplasty * low transparec of corneae * low visual acuity Exclusion Criteria: * active anterior segment pathology * previous corneal or anterior segment surgery * any infection
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Macular corneal dystrophy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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.
-
The places running it
1 site. The list below names each one and where it is.
-
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.
-
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