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Epi-ON corneal crosslinking: 18-minute versus 24-minute UVA exposure for ectatic corneas

Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure Versus a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases

Phase 3 Interventional Woolfson Eye Institute · NCT07124910

This test compares whether an 18-minute or a 24-minute Epi-ON corneal crosslinking procedure better slows progression in people with keratoconus or other ectatic corneal conditions.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment485 (estimated)
Ages8 Years and up
SexAll
SponsorWoolfson Eye Institute Academic / other
Locations12 sites (Atlanta, Georgia and 11 other locations)
Trial IDNCT07124910 on ClinicalTrials.gov

What this trial studies

This phase 3 trial enrolls patients aged 8 and older with keratoconus or other corneal ectasias to receive Epi-ON (epithelium-intact) corneal collagen crosslinking using riboflavin drops and UVA light. Participants will undergo crosslinking with either an 18-minute or a 24-minute UVA exposure and will be followed at scheduled visits to measure corneal shape, thickness, and visual acuity. The study compares the two exposure durations to determine if the shorter protocol is as effective and safe as the longer one. Outcomes include progression of ectasia and changes in vision over the follow-up period.

Who should consider this trial

Good fit: Ideal candidates are people aged 8 or older with a diagnosis of keratoconus, post-LASIK or post-PRK ectasia, pellucid marginal degeneration, progressive ectasia after prior CXL, or forme fruste keratoconus who can attend in-person visits and provide informed consent.

Not a fit: Patients with corneas that are too thin for safe crosslinking, active ocular infection, or other contraindications (including pregnancy) may not receive benefit from this procedure.

Why it matters

Potential benefit: If successful, the optimized UVA exposure could better halt or slow corneal thinning and vision loss while potentially shortening treatment time and discomfort.

How similar studies have performed: Epithelium-off CXL has strong evidence for stopping ectatic progression, while transepithelial (Epi-ON) approaches and accelerated shorter-duration protocols have shown mixed results and are still being tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Atlanta, Georgia and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions KeratoconusEctasia of CorneaPellucid Marginal Corneal DegenerationForme Fruste KeratoconuscrosslinkingcornealEpi-ONUVA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.