Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

NCT01464268 | Unknown Phase 3

• 1 other identifier: CLEI-EpiCXL
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus; Corneal Ectasia

Keywords

Keratoconus; Corneal Ectasia; Collagen Crosslinking; Riboflavin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Manifest refraction

  12 months

• Visual Acuity

  12 months

• Endothelial cell density

  12 months

Study Arms (2)

Riboflavin drops every minute

ACTIVE COMPARATOR

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

Drug: Riboflavin

Riboflavin drops every 2 minutes

ACTIVE COMPARATOR

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

Drug: Riboflavin

Interventions

Riboflavin DRUG

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

Also known as: Riboflavin without dextran

Riboflavin drops every 2 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cornea and Laser Eye Institute: lead

Study Sites (1)

Cornea and Laser Eye Institute

Teaneck, New Jersey, 07666, United States

Location

Related Publications (2)

• 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.

  PMID: 21183110 BACKGROUND

• 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.

  PMID: 32557558 DERIVED

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin; Dextrans

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Study Officials

• Peter Hersh, MD

  Cornea and Laser Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 3, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (1)