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Could a simple Pre-Transplant treatment give keratoconus patients sharper vision?

NCT ID NCT04584125

Disease control Sponsor: Joseph B. Ciolino, MD 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests whether treating donor corneal tissue with a cross-linking procedure before transplant can improve vision and reduce astigmatism in people with keratoconus. About 216 adults aged 18–50 who need a corneal transplant will receive either cross-linked or standard donor tissue. The goal is to see if the treated tissue stays stronger and leads to better long-term eyesight.

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

About 216 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Nov 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

18 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: * Willing and able to provide written informed consent. * Willing and able to comply with study assessments for the full duration of the study. * Age ≥18 years but ≤50 years * History of keratoconus (without a previous transplant) requiring keratoplasty * Willing to commit to not having further cross-linking, corneal relaxing incisions, intacs, or corneal laser vision correction during the course of the study Exclusion Criteria: * Age \< 18 years \>50 * Inability to provide written informed consent and comply with study assessments for the full duration of the study * Participation in another simultaneous interventional medical investigation or trial Systemic * History of Stevens-Johnson syndrome or ocular pemphigoid * Signs of current infection, including fever and current treatment with antibiotics * Pregnancy (positive pregnancy test) or lactating * Pre-menopausal sexually active women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method) Recipient Eye * Corneal or ocular surface infection within 30 days prior to study entry * History of previous cross-linking * History of previous corneal transplant * Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively * Ocular or periocular malignancy * Lid abnormalities that in the opinion of the investigator could confound the study results and these include clinically significant ectropion, lagophthalmos, cicatrization, entropion, and rosacea * Neurotrophic cornea * Monocular * Uncontrolled glaucoma * Glaucoma filtering devices or trabeculectomies

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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

How to take part

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

  1. The places running it

    1 site. 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

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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