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Shorter light therapy may be just as good for treating bulging corneas

NCT ID NCT07124910

Disease control Sponsor: Woolfson Eye Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether a shorter 18-minute ultraviolet (UVA) light exposure works as well as the standard 24-minute exposure during corneal crosslinking for keratoconus and similar conditions. The treatment uses riboflavin (vitamin B2) eye drops followed by UVA light to strengthen the cornea and stop vision loss. About 485 participants aged 8 and older will be followed for 6 months to compare changes in corneal shape and eyesight between the two groups.

What this could mean

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

Active substance
riboflavin (vitamin B2) eye drops plus ultraviolet (UVA) light
What this could lead to
If it works, this could show that a shorter 18-minute UVA exposure is just as effective as the standard 24-minute one, making treatment faster and more comfortable.
What could go wrong
This is still an experimental treatment not yet FDA-approved. The trial is relatively small and only follows participants for 6 months, so long-term benefits and risks are unknown.

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

About 485 people

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

Started

Aug 2025

Expected to finish

Dec 2028

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

8 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: Subjects in whom both the subject and study eye meet all of the following criteria are candidates for the study: 1. Be at least 8 years of age or older, male or female, of any race. 2. Have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus based on topography, tomography, and slit lamp examination. 3. Provide written informed consent and a signed HIPAA form. Pediatric subjects less than 14 years of age must sign an assent, and a parent or legal guardian must sign an informed consent. 4. Be willing and able to follow all instructions and comply with the schedule for follow-up visits. 5. If female and capable of becoming pregnant, must not be lactating or pregnant and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue one month following treatment. Exclusion Criteria: Subjects in whom the subject or study eye meets one or more of the following criteria will be excluded from the randomized cohort of the study: 1. Normal corneal topography. 2. A history of previous corneal transplant in the study eye. 3. Minimum corneal thickness \< 300 (measured by Pentacam and Ultrasound) at the screening exam. 4. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent the possibility of improved vision, for example: 1. History of or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) 2. Clinically significant corneal scarring in the central cornea that, in the investigator's opinion, will not allow the subject to achieve functional vision, even with contact lens correction, after the crosslinking procedure. 5. A known contraindication, sensitivity, or allergy to the test article or its components or to study medications. 6. Nystagmus or any other condition that would prevent a steady gaze during the crosslinking treatment or other diagnostic tests. 7. If female, pregnant, nursing or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of either eye during the course of the study. 8. Inability to remove soft or scleral contact lenses at least 3 days before initial and follow-up examinations. 9. Inability to remove rigid gas-permeable contact lenses at least 2 weeks before initial and follow-up examinations. 10. Inability to return for required postoperative examinations. 11. Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for crosslinking or study participation or may confound the outcome of the study.

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Conditions

The condition(s) this trial relates to.

corneal ectasia keratoconus pellucid marginal degeneration

As listed by the trial registrant

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

Ectasia of cornea Forme fruste keratoconus (FFK) Keratoconus Pellucid marginal corneal degeneration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Woolfson Eye Institute

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Woolfson Eye Institute

    RECRUITING

    Atlanta, Georgia, 30349, United States

  • Woolfson Eye Institute

    RECRUITING

    Canton, Georgia, 30114, United States

  • Woolfson Eye Institute

    RECRUITING

    Cumming, Georgia, 30041, United States

  • Woolfson Eye Institute

    RECRUITING

    Douglasville, Georgia, 30134, United States

  • Woolfson Eye Institute

    RECRUITING

    Lawrenceville, Georgia, 30043, United States

  • Woolfson Eye Institute

    RECRUITING

    Marietta, Georgia, 30066, United States

  • Woolfson Eye Institute

    RECRUITING

    Snellville, Georgia, 30078, United States

  • Woolfson Eye Institute

    RECRUITING

    Asheville, North Carolina, 28803, United States

  • Woolfson Eye Institute

    RECRUITING

    Chattanooga, Tennessee, 37421, United States

  • Woolfson Eye Institute

    RECRUITING

    Johnson City, Tennessee, 37615, United States

  • Woolfson Eye Institute

    RECRUITING

    Knoxville, Tennessee, 37922, United States

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