Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

• ClinicalTrials.gov Identifier: NCT01464268
• Recruitment Status: Active, not recruiting
• First Posted: November 3, 2011
• Last Update Posted: January 26, 2021
• Sponsor: Cornea and Laser Eye Institute
• Information provided by (Responsible Party): Cornea and Laser Eye Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Keratoconus; Corneal Ectasia	Drug: Riboflavin	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia
• Study Start Date: November 2011
• Estimated Primary Completion Date: February 2021
• Estimated Study Completion Date: February 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Riboflavin drops every minute; Administration of riboflavin every 2 minutes for the duration of UV exposure.	Drug: Riboflavin; Administration of riboflavin every 1 minute for the duration of UV exposure.; Other Name: Riboflavin without Dextran
Active Comparator: Riboflavin drops every 2 minutes; Administration of riboflavin every 1 minute for the duration of UV exposure.	Drug: Riboflavin; Administration of riboflavin every 2 minutes for the duration of UV exposure.; Other Name: Riboflavin without dextran

Outcome Measures

Primary Outcome Measures :

1. Maximum Keratometry [ Time Frame: 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 :

1. Manifest refraction [ Time Frame: 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.
2. Visual Acuity [ Time Frame: 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.
3. Endothelial cell density [ Time Frame: 12 months ]
   Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New Jersey

Cornea and Laser Eye Institute

Teaneck, New Jersey, United States, 07666

Sponsors and Collaborators

Cornea and Laser Eye Institute

Investigators

• Principal Investigator: Peter Hersh, MD; Cornea and Laser Eye Institute

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

• Responsible Party: Cornea and Laser Eye Institute
• ClinicalTrials.gov Identifier: NCT01464268
• Other Study ID Numbers: CLEI-EpiCXL
• First Posted: November 3, 2011
• Last Update Posted: January 26, 2021
• Last Verified: January 2020

Keywords provided by Cornea and Laser Eye Institute:

Keratoconus; Corneal Ectasia; Collagen Crosslinking; Riboflavin

Additional relevant MeSH terms:

Keratoconus; Corneal Diseases; Dilatation, Pathologic; Eye Diseases; Pathological Conditions, Anatomical; Riboflavin; Dextrans; Vitamin B Complex; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Anticoagulants; Plasma Substitutes; Blood Substitutes