A Phase 3 interventional study of Epi-ON corneal cross-linking in Keratoconus, Ectasia of Cornea and Pellucid Marginal Corneal Degeneration, sponsored by Woolfson Eye Institute. Recruiting at 12 sites in United States. Open to participants aged 8 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Woolfson Eye Institute · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred.
CXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be at least 8 years of age or older and have a diagnosis of keratoconus, ectasia after LASIK, ectasia after PRK, pellucid marginal degeneration, progressive ectasia after previous CXL treatment or forme fruste keratoconus.
The main question it aims to answer is:
Participants will:
Receive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light).
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 485 is above the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Woolfson Eye Institute is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects in whom both the subject and study eye meet all of the following criteria are candidates for the study:
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:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who meet the inclusion criteria and provide informed consent will be randomized to receive UVA irradiation with 15-second off-on cycling for either 18 minutes or 24 minutes
Combination Product: Epi-ON corneal cross-linking
Subjects who meet the inclusion criteria and provide informed consent will be randomized to receive UVA irradiation with 15-second off-on cycling for either 18 minutes or 24 minutes
Combination Product: Epi-ON corneal cross-linking
Corneal cross-linking involves the following steps: * applying riboflavin (Vitamin B2 eye drops) to the eye, then * exposing the eye to ultraviolet (UV-A) light
The primary outcome measures for efficacy is corneal curvature, as measured by Kmax with the Pentacam, in the treated eyes and CDVA.
The change in keratometry (Kmax) and corrected visual acuity from baseline will be evaluated at 6 months for all eyes treated. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests. The change in Kmax and corrected visual acuity from baseline will be evaluated at 6 months.
Time frame: From enrollment to the end of treatment at 6 months.
Change in UCVA compared to the baseline examination will be used as a Secondary outcome measurement.
Change in UCVA compared to the baseline examination will be evaluated at 6 months postoperatively. Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: 6 months
At the Sponsor-Investigator's discretion, the change in HOA from baseline may be evaluated at 6 months postoperatively for the eyes that underwent preoperative and postoperative wavefront testing.
Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: 6 months
At the Sponsor-Investigator's discretion, the change in coma from baseline may be evaluated at 6 months postoperatively for the eyes that underwent preoperative and postoperative wavefront testing.
Data will be summarized using descriptive statistics and experimental groups will be compared using nonparametric tests.
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Nov 2028, 39 months after the start.
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Woolfson Eye Institute