Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Keratoconus Clinical Trial

Official title:

Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01464268
• Other study ID #: CLEI-EpiCXL
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 2011
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: Cornea and Laser Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Corneal Diseases
• Corneal Ectasia
• Keratoconus

Intervention

Drug:
• Riboflavin
Administration of riboflavin every 2 minutes for the duration of UV exposure.
• Riboflavin
Administration of riboflavin every 1 minute for the duration of UV exposure.

Locations

Country	Name	City	State
United States	Cornea and Laser Eye Institute	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Cornea and Laser Eye Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hersh PS, Greenstein SA, Fry KL. Corneal collagen crosslinking for keratoconus and corneal ectasia: One-year results. J Cataract Refract Surg. 2011 Jan;37(1):149-60. doi: 10.1016/j.jcrs.2010.07.030. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Keratometry	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	12 months
Secondary	Manifest refraction	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.	12 months
Secondary	Visual Acuity	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.	12 months
Secondary	Endothelial cell density	Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively.	12 months