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Could a light treatment for donor eyes save more sight?

NCT ID NCT06753916

Disease control Sponsor: Massachusetts Eye and Ear Infirmary 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This study tests whether treating donor corneal tissue with a special light-based process (cross-linking) before transplant can make it last longer and reduce rejection in people at high risk of graft failure. About 96 adults who need a high-risk cornea transplant will receive either a treated or standard donor cornea. The main goal is to check safety and see if the treated tissue lowers the chance of rejection or graft failure over two years.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 96 people

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

Started

Apr 2025

Expected to finish

Jan 2031

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 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: * Age 18 and older * Willing and able to provide written informed consent * Willing and able to comply with study assessments for the full duration of the study * Patients undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (NV) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal NV to the graft-host junction in a previously failed graft * Superficial vessels are defined as those within the anterior one-third of the cornea and deep vessels within the posterior two-thirds of the cornea (i.e., deep stroma). Superficial CNV involving ≤2 quadrants (equivalent to ≤6 clock hours) without deep CNV are classified as mild. CNV with \>2 quadrants of superficial vessels (\>6 clock hours) or 1 quadrant of deep vessels (\>3 clock hours) as severe (36). Exclusion Criteria: * History of Stevens-Johnson syndrome or ocular pemphigoid * Ocular or periocular malignancy * Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively * Uncontrolled glaucoma * Change in topical corticosteroid regimen within 14 days of transplantation * Use of systemic immunosuppressive for indication other than corneal graft rejection * Participation in another simultaneous medical investigation or trial * Pregnancy (positive pregnancy test) or lactating * Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method) * Ocular infection within 30 days prior to study entry. * Presence of anterior chamber intraocular lens * Active uveitis within 90 days prior to the study entry. * No ocular surgery or procedure within 90 days prior to the study entry or concomitant to the study procedure.

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Conditions

The condition(s) this trial relates to.

corneal neovascularization transplant rejection

As listed by the trial registrant

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

Corneal transplant failure

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

  • Cincinnati Eye Institute

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Duke University - Duke Eye Center

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Kansas City Eye Clinic

    RECRUITING

    Overland Park, Kansas, 66204, United States

  • Massachusetts Eye and Ear

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mid-Atlantic Cornea Consultant

    RECRUITING

    Towson, Maryland, 21204, United States

  • Price Vision Group

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • The University of California Los Angeles - Doris Stein Eye Research Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • University of California Irvine - Gavin Herbert Eye Institute

    NOT_YET_RECRUITING

    Irvine, California, 92617, United States

  • University of California San Francisco - Wayne and Gladys Valley Center for Vision

    NOT_YET_RECRUITING

    San Francisco, California, 94158, United States

  • University of Miami - Bascom Palmer Eye Institute

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan - Kellogg Eye Center

    RECRUITING

    Ann Arbor, Michigan, 48015, United States

  • Wake Forest Baptist Eye Center

    NOT_YET_RECRUITING

    Bermuda Run, North Carolina, 27006, United States

More trials for these conditions

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