Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 17, 2014
Last verified: September 2014

November 1, 2011
September 17, 2014
November 2011
February 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01464268 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia
Transepithelial Corneal Collagen Crosslinking for Keratoconus and Corneal Ectasia

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Keratoconus
  • Corneal Ectasia
  • Drug: Riboflavin
    Administration of riboflavin every 2 minutes for the duration of UV exposure.
    Other Name: Riboflavin without dextran
  • Drug: Riboflavin
    Administration of riboflavin every 1 minute for the duration of UV exposure.
    Other Name: Riboflavin without Dextran
  • Active Comparator: Riboflavin drops every minute
    Administration of riboflavin every 2 minutes for the duration of UV exposure.
    Intervention: Drug: Riboflavin
  • Active Comparator: Riboflavin drops every 2 minutes
    Administration of riboflavin every 1 minute for the duration of UV exposure.
    Intervention: Drug: Riboflavin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
February 2016
February 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Stacey Lazar 201-883-0505 info@vision-institute.com
United States
 
NCT01464268
CLEI-EpiCXL
No
Cornea and Laser Eye Institute
Cornea and Laser Eye Institute
Not Provided
Principal Investigator: Peter Hersh, MD Cornea and Laser Eye Institute
Cornea and Laser Eye Institute
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP