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Could a donated corneal lens fix farsightedness after cataract surgery?

NCT ID NCT04692012

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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, donated corneal lenticule — a thin layer of corneal tissue — can safely correct residual farsightedness in people who already have an artificial lens implant after cataract surgery. The procedure uses a femtosecond laser to create a pocket in the cornea and insert the donor tissue. The goal is to improve visual acuity without the risks associated with LASIK or refractive lens exchange.

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 myopic lenticule implantation (ReLex-SMILE surgery)
What this could lead to
If successful, this could offer a safer surgical option for correcting residual farsightedness in patients with artificial lens implants, avoiding complications of LASIK or lens exchange.
What could go wrong
This is a small, early-stage trial with only 34 participants. Risks include infection, refractive errors, and the need for additional procedures like YAG-laser capsulotomy.

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

34 people

The number who actually took part.

Started

Apr 2018

Expected to finish

Feb 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 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: * residual hypermetropic refraction on pseudophakic patients * low visual acuity Exclusion Criteria: * active anterior segment pathologic features, * previous corneal or anterior segment surgery, * glaucoma, * retinal detachment

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Conditions

The condition(s) this trial relates to.

hyperopia myopia Pseudophakia

As listed by the trial registrant

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

Hypermetropia Myopia Pseudophakia

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.