Epi-On Corneal Crosslinking for Keratoconus

Phase 4

Completed

• Conditions: Keratoconus, Unstable; Keratoconus
• Interventions: Drug: Riboflavin 5'-Phosphate

• Registration Number: NCT03245853
• Lead Sponsor: Comprehensive EyeCare of Central Ohio

Brief Summary

Epithelium-On Corneal Crosslinking for Keratoconus.

Detailed Description

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).

Study Timeline

• Study Start: 2017-07-18
• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-10
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Riboflavin 5'-Phosphate	Treatment as per protocol, there is no placebo arm.

Primary Outcome Measures

Name	Time	Method
Maximum keratometric change	12 months	Change from baseline keratometric maximum over time.

Secondary Outcome Measures

Name	Time	Method
Visual acuity change	12 months	Change from baseline uncorrected distance visual acuity and best spectacle-corrected visual acuity.

Trial Locations

Locations (1)

Comprehensive EyeCare of Central Ohio; 🇺🇸 Westerville, Ohio, United States