Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome

Launched by CLINICAL RESEARCH CONSULTANTS, INC. · Aug 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called corneal crosslinking (CXL) for people with Down syndrome who have certain eye conditions where the cornea—the clear front part of the eye—becomes thin, steep, and misshapen. These changes can cause blurry vision and may get worse over time. The treatment involves putting vitamin B2 drops on the eye and then shining a special type of light (similar to sunlight) on it for about 20 minutes. This process aims to strengthen the cornea and stop the eye condition from getting worse.

People who are 8 years or older with Down syndrome and a diagnosed corneal problem like keratoconus or related conditions may be able to join. Participants will visit the doctor up to seven times over six months to have eye exams and tests. During the treatment visit, they will receive the vitamin drops and light therapy. The study wants to find out if this treatment can help slow down or prevent further vision loss. It’s important that participants can follow instructions and attend all visits. If you or a family member fits these conditions and are interested, this study might offer a new option to help protect vision.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be at least 8 years of age or older, male or female, of any race.
• • 2. Have a diagnosis of Down syndrome or other cognitive, developmental, or medical conditions that precludes the subject from reliably following instructions or performing some of the study examination procedures.
• • 3. Have a diagnosis of keratoconus, pellucid marginal degeneration, progressive ectasia after previous CXL treatment, other ectatic condition, or forme fruste keratoconus based on topography, tomography, and slit lamp examination.
• • 4. 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. If the subject has impaired consent capacity, determined by the consenter, the consent form must be signed by the subject's legally authorized representative on behalf of the subject.
• • 5. Satisfactory completion of the standardized clinical decision tool evaluation of patient suitability for CXL. (See Section 7.2.3)
• • 6. Be willing and able to follow all instructions to the best of his/her abilities and comply with the schedule for follow-up visits.
• Exclusion Criteria:
• • 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, lactating 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. \[NOTE: If female and capable of becoming pregnant, must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue one month following treatment. \]
• • 7. Inability to remove soft or scleral contact lenses at least 3 days before initial and follow-up examinations.
• • 8. Inability to remove rigid gas-permeable contact lenses at least 2 weeks before initial and follow-up examinations.
• • 9. Inability to return for required postoperative examinations. 10. 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.