Epi-On Corneal Crosslinking for Keratoconus

Study Overview
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Brief Summary
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Epithelium-On Corneal Crosslinking for Keratoconus.

Detailed Description
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Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for Corneal Crosslinking (CXL). Subjects that as candidates for CXL will be asked to participate in this study and will undergo the required screening procedures to determine study eligibility. Informed consent will be obtained from each subject before performance of any required any required study procedures that are not part of the investigator's routine examination. All Subjects will be evaluated at screening/baseline, Day 0 (treatment day), then 1 day, 1 week, and 1, 3, 6, 12 months after treatment. Pentacam measurements and measurements of best spectacle-corrected visual acuity will be obtained and baseline and at appropriate times after the epithelium-on CXL procedure. Safety monitoring throughout the study will include observations at appropriate times for adverse events, clinically significant findings on ophthalmic examination, and slit-lamp examination. The primary efficacy parameter is the change from baseline over time in maximum keratometry (K-Max). Addition analyses for efficacy will include uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA).

Official Title
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Epithelium-On Corneal Collagen Crosslinking for Keratoconus

Conditions
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Keratoconus, Keratoconus, Unstable

Intervention / Treatment
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* Drug: Riboflavin 5'-Phosphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 12 to 40 years of age, having a diagnosis of keratoconus, signed written informed consent, willingness and ability to comply with schedule for follow-up visits Exclusion Criteria: Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications (herpes simplex/zoster, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.) Pregnancy, intent to become pregnant, or lactation during study. Corneal pachymetry <350 microns at the thinnest point measured by Pentacam in the eye(s) to be treated. Nystagmus or any other condition that would prevent steady gaze. Other systemic condition that in the investigator's opinion would not allow the patient to be a good candidate for the study.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects with a diagnosis of progressive keratoconus will be evaluated for suitability as a candidate for CXL. Subjects that are candidates for CXL will be asked to participate in this study and will undergo required screening testing. Informed consent will be obtained from each subject prior to study-oriented testing.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>Treatment as per protocol, there is no placebo arm. | Drug: Riboflavin 5'-Phosphate<br>* Photrexa (riboflavin 5'-phosphate ophthalmic solution) 0.146%, is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5'-phosphate, The pH of the solution is approximately 7.1 and the osmolarity is 157-177 mOsm/kg. Each 1 mL of the solution contains 1.53 mg of riboflavin 5'-phosphate sodium (equivilant to 1.20 mg [0.12%] riboflavin). Riboflavin 5'-phosphate sodium USP is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, monbasic sodium phosphate, sodium chloride, and water for injection.<br>* Other names: Photrexa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum keratometric change | Change from baseline keratometric maximum over time. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity change | Change from baseline uncorrected distance visual acuity and best spectacle-corrected visual acuity. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CXL, Keratoconus, Corneal Crosslinking