Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia

Phase 3

Recruiting

• Conditions: Corneal Ectasia; Keratoconus
• Interventions: Drug: Riboflavin

• Registration Number: NCT04905108
• Lead Sponsor: Cornea and Laser Eye Institute

Brief Summary

Corneal collagen crosslinking (CXL) has been demonstrated as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection and scarring, faster visual recovery and improved patient comfort in the early postoperative healing period.

Detailed Description

The objective of this randomized study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslinking procedure. The primary objective of this study is to evaluate the safety and efficacy of transepithelial corneal collagen crosslinking performed with two different riboflavin administration protocols during the UVA portion of the procedure. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, the two groups will be compared with regard to their efficacy in reducing corneal curvature. Secondary outcomes will include visual acuity. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, and slit lamp examination.

Study Timeline

• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-27
• Study Start: 2021-06-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-30
• Last Update Posted: 2023-01-04
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 12 years of age or older
• Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK])
• Presence of central or inferior steepening on the Pentacam map
• Axial topography consistent with keratoconus or post-surgical corneal ectasia
• Contact lens wearers only: Removal of contact lenses for the required period of 1 week prior to the screening refraction
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits

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Exclusion Criteria

• Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme

• Corneal pachymetry measuring 300 microns or less at the thinnest point measured by Pentacam in the eye(s) to be treated

• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

  1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
  2. Clinically significant corneal scaring in the CXL treatment zone

• A history of chemical injury or delayed epithelial healing in the eye(s) to be treated

• Pregnancy (including plan to become pregnant) or lactation during the course of the study

• A known sensitivity to study medications

• Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests

• Patients with a current condition that,in the investigator's opinion, would interfere with or prolong epithelial healing

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Riboflavin drop every 10 minutes	Riboflavin	Administration of one drop of Riboflavin every 10 minutes during UV exposure
Riboflavin drop every 2 minutes	Riboflavin	Administration of one drop of Riboflavin every 2 minutes during UV exposure

Primary Outcome Measures

Name	Time	Method
Maximum keratometry	12 months	The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.

Secondary Outcome Measures

Name	Time	Method
Mean keratometry	1 year	The change in mean keratometry (Mean K) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.

Trial Locations

Locations (1)

Cornea and Laser Eye Institute, Hersh Vision Group; 🇺🇸 Teaneck, New Jersey, United States