Status:
NOT_YET_RECRUITING
Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome
Lead Sponsor:
Clinical Research Consultants, Inc.
Conditions:
Down Syndrome (DS)
Keratoconus
Eligibility:
All Genders
8+ years
Phase:
PHASE3
Brief Summary
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 cor...
Eligibility Criteria
Inclusion
- Be at least 8 years of age or older, male or female, of any race.
- 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.
- 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.
- 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.
- Satisfactory completion of the standardized clinical decision tool evaluation of patient suitability for CXL. (See Section 7.2.3)
- 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
- Normal corneal topography.
- A history of previous corneal transplant in the study eye.
- Minimum corneal thickness \< 300 (measured by Pentacam and Ultrasound) at the screening exam.
- 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:
- History of, or active, corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
- 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.
- A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
- Nystagmus or any other condition that would prevent a steady gaze during the crosslinking treatment or other diagnostic tests.
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT07135167
Start Date
August 1 2025
End Date
February 1 2026
Last Update
August 21 2025
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