Epi-On Corneal Crosslinking for Keratoconus

Status Completed

Clinical Trial Summary

Epithelium-On Corneal Crosslinking for Keratoconus.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03245853
Study type	Interventional
Source	Comprehensive EyeCare of Central Ohio
Contact
Status	Completed
Phase	Phase 4
Start date	July 18, 2017
Completion date	September 30, 2019

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See also
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