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New eye procedure could stop keratoconus without removing cornea layer

NCT ID NCT07173907

Disease control Sponsor: Gemini Eye Clinic 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested two ways to treat keratoconus, a condition where the cornea thins and bulges. One method removes the cornea's outer layer before treatment, while the other keeps it intact and customizes the light pattern. Researchers followed 135 adults for 24 months to see which approach better stabilizes the cornea and improves vision. The goal is to find a treatment that is both effective and more comfortable for patients.

What this could mean

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

Active substance
Corneal cross-linking (CXL) procedure using riboflavin and UVA light
What this could lead to
If successful, this could offer a more comfortable and equally effective way to stop keratoconus from getting worse, potentially improving vision without removing the cornea's surface layer.
What could go wrong
This is a completed study with 135 participants, but it compares two established procedures rather than testing a new breakthrough. Results may show no major advantage for either method, and individual outcomes can vary.

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.

Participants

135 people

The number who actually took part.

Started

Jan 2016

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with keratoconus grades 1 to 3-4 undergoing corneal cross-linking (CXL) treatment as part of routine clinical care.

Ages

18 years and older

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: * adult eyes * progressive keratoconus (grades 1 to 3-4, Krumeich-Amsler classification) * corneal thickness ≥400 μm * endothelial cell density ≥1500 cells/mm² Exclusion Criteria: * prior corneal surgeries * corneal scars * dystrophies * marginal pellucid degeneration * systemic connective tissue disorders * uncontrolled diabetes * pregnancy, or breastfeeding.

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Conditions

The condition(s) this trial relates to.

keratoconus

As listed by the trial registrant

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

Keratoconus

More trials for these conditions

Other studies related to the condition(s) this trial covers.