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Can a donated corneal lens correct hard-to-tract high hyperopia and astigmatism?

NCT ID NCT04616144

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tests whether implanting a fresh corneal lenticule — a thin layer of donor cornea — can improve vision in people with high hyperopia (farsightedness) and high astigmatism. The lenticule is placed using a femtosecond laser, aiming to increase visual acuity and reduce astigmatism. The study includes 55 participants with specific corneal thickness and refractive requirements.

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 implanted using a femtosecond laser
What this could lead to
If successful, this approach could offer a surgical option for people with high hyperopia and high astigmatism who have few alternatives.
What could go wrong
This is a single-center study with 55 participants, so results may not apply broadly. Risks include infection, inflammation, or the lenticule not integrating properly.

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 55 people

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

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

20 to 50 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 with high spherical hyperopia over + 4.5 D * astigmatism over + 3 cyl. * corneal thickness minimum 450 µm and maximum 550 µm. Exclusion Criteria: * corneal thickness over 550 µm * history of glaucoma * retinal detachment * cataract * history of ocular inflammation.

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Conditions

The condition(s) this trial relates to.

astigmatism hyperopia

As listed by the trial registrant

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

High astigmatism Hyperopia

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.