Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Phase 3

Active, not recruiting

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

• Registration Number: NCT01464268
• Lead Sponsor: Cornea and Laser Eye Institute

Brief Summary

Corneal collagen crosslinking (CXL) has been proposed 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. During previous studies of the CXL procedure, the surface epithelial cells have been removed. 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 as no epithelial barrier will be broken, faster visual recovery and improved patient comfort in the early postoperative healing period.

Detailed Description

The objective of this 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 riboflavin 0.1% for reducing corneal curvature. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, we will compare the two groups 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, slit lamp examination of the cornea and lens, and contact lens tolerance for contact lens wearers

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-03
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

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

Inclusion Criteria

• 18 years of age or older
• A diagnosis of keratoconus or a diagnosis of corneal ectasia after corneal refractive surgery
• Vision with contact lenses or glasses is worse than 20/20
• Corneal thickness greater than 375 microns at the thinnest point

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Exclusion Criteria

• Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
• Corneal pachymetry ≤ 350 microns 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
• Clinically significant corneal scarring in the CXL treatment zone
• 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 drops every 2 minutes	Riboflavin	Administration of riboflavin every 1 minute for the duration of UV exposure.
Riboflavin drops every minute	Riboflavin	Administration of riboflavin every 2 minutes for the duration of 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 to the two treatment groups. As a secondary analysis of this endpoint, the change in maximum keratometry (Kmax) from baseline will be evaluated at 1, 3 and 6 month for all eyes

Secondary Outcome Measures

Name	Time	Method
Manifest refraction	12 months	The change in manifest refraction spherical equivalent from baseline will be evaluated at 12 months. As a secondary analysis of this endpoint, a repeated measures analysis of variance will be conducted to assess the profile of the treatments across time at 1,3, and 6 months to look at the effect of wound healing on this variable.
Visual Acuity	12 months	Change in BSCVA (best spectacle corrected visual acuity) and UCVA (uncorrected visual acuity) compared to the baseline examination will be evaluated at 12 months postoperatively. As a secondary analysis of this endpoint, data across time from 1, 3, and 6 months following the CXL procedure will be analyzed.
Endothelial cell density	12 months	Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively.

Trial Locations

Locations (1)

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