Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

This study is currently recruiting participants.
Verified July 2013 by Cornea and Laser Eye Institute
Sponsor:
Information provided by (Responsible Party):
Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier:
NCT01464268
First received: November 1, 2011
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Keratoconus
Corneal Ectasia
Drug: Riboflavin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

Resource links provided by NLM:


Further study details as provided by Cornea and Laser Eye Institute:

Primary Outcome Measures:
  • Maximum Keratometry [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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:
  • Manifest refraction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to CXL treatment and at 12 months postoperatively.


Estimated Enrollment: 160
Study Start Date: November 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 ≤ 375 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464268

Contacts
Contact: Stacey Lazar 201-883-0505 info@vision-institute.com

Locations
United States, New Jersey
Cornea and Laser Eye Institute Recruiting
Teaneck, New Jersey, United States, 07666
Contact: S Lazar    201-883-0505    info@vision-institute.com   
Principal Investigator: Peter S Hersh, MD         
Sponsors and Collaborators
Cornea and Laser Eye Institute
Investigators
Principal Investigator: Peter Hersh, MD Cornea and Laser Eye Institute
  More Information

Publications:
Responsible Party: Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier: NCT01464268     History of Changes
Other Study ID Numbers: CLEI-EpiCXL
Study First Received: November 1, 2011
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cornea and Laser Eye Institute:
Keratoconus
Corneal Ectasia
Collagen Crosslinking
Riboflavin

Additional relevant MeSH terms:
Dilatation, Pathologic
Keratoconus
Corneal Diseases
Pathological Conditions, Anatomical
Eye Diseases
Dextrans
Riboflavin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Dermatologic Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 21, 2014