Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

NCT ID: NCT01464268

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2025-12-31

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

Conditions

Keratoconus; Corneal Ectasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Riboflavin drops every minute

Administration of riboflavin every 2 minutes for the duration of UV exposure.

Group Type: ACTIVE_COMPARATOR

Riboflavin

Intervention Type: DRUG

Administration of riboflavin every 1 minute for the duration of UV exposure.

Riboflavin drops every 2 minutes

Administration of riboflavin every 1 minute for the duration of UV exposure.

Group Type: ACTIVE_COMPARATOR

Riboflavin

Intervention Type: DRUG

Administration of riboflavin every 2 minutes for the duration of UV exposure.

Interventions

Riboflavin

Administration of riboflavin every 2 minutes for the duration of UV exposure.

Intervention Type: DRUG

Riboflavin

Administration of riboflavin every 1 minute for the duration of UV exposure.

Intervention Type: DRUG

Other Intervention Names

Riboflavin without dextran; Riboflavin without Dextran

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cornea and Laser Eye Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Hersh, MD

Role: PRINCIPAL_INVESTIGATOR

Cornea and Laser Eye Institute

Locations

Cornea and Laser Eye Institute

Teaneck, New Jersey, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21183110 (View on PubMed)

Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.

Reference Type: DERIVED

PMID: 32557558 (View on PubMed)

Other Identifiers

CLEI-EpiCXL

Identifier Type: -

Identifier Source: org_study_id