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Eye-Strengthening light therapy tested to halt blinding cornea disease

NCT ID NCT01604135

Disease control Sponsor: Sahlgrenska University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests a procedure called corneal collagen crosslinking for people with progressive keratoconus, a condition where the cornea thins and bulges, blurring vision. The treatment uses riboflavin (vitamin B2) drops and UV light to stiffen the cornea. The study aims to see if it can stop the cornea from getting steeper over 12 months, potentially preventing the need for a cornea transplant.

What this could mean

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

Active substance
corneal collagen crosslinking (a procedure using riboflavin drops and UV light to strengthen the cornea)
What this could lead to
If it works, this could offer a way to halt keratoconus progression and avoid the need for a cornea transplant.
What could go wrong
This is a small, early-phase trial with only 36 participants, so results may not apply to everyone. The procedure may not stop progression in all cases, and there are risks like infection or corneal haze.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

36 people

The number who actually took part.

Started

May 2012

Expected to finish

Apr 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

18 to 30 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: * Keratoconus diagnosis determined clinically and topographically (KISA%- index) * Significant progression is defined as change (increase) of Kmax by at least 1D from baseline at 6 months and/or change (increase) of Sim-K-ast by at least 1D from baseline at 6 months. Kmax is defined as the steepest radius of curvature (either the maximum simulated K-reading or the maximum K-reading in the 3-mm zone or the 5-mm zone) of the anterior corneal surface that progressed the most during 6 months observation * Ability to stop contact lens (rigid and soft) wear at least two weeks prior to next exam * Signed written informed consent Exclusion Criteria: * Age \< 18 years * Pregnancy * Breast feeding * History of corneal surgery * History of ocular herpes simplex infection * Minimal corneal thickness \< 300 micrometers * Recurrent corneal erosions * Other corneal (e g endothelial) or conjunktival diseases * Neurodermatitis * Severe forms av atopic disease * Collagenoses, autoimmune or other systemic disease * Systemic treatment with high doses of steroids * Severe scarring och striae of the cornea Relative exclusion criteria: * Kmax \> 58D * Minimal corneal thickness \< 400 micrometers (a modified CXL-treatment will be used swelling the cornea before UV-illumination treatment).

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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

Contacts and locations

Locations

  • Department of Ophthalmology, Sahlgrenska University Hospital

    Mölndal, Västra Götalandsregionen, 43180, Sweden

More trials for these conditions

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