CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Keratoconus Clinical Trial

Official title:

Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01956474
• Other study ID #: CXL-04
• Status: Terminated
• Phase: Phase 2
• Start date: January 2013
• Est. completion date: February 3, 2017

Study information

• Verified date: October 2018
• Source: Cxlusa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin.

Description:

This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1324
• Est. completion date: February 3, 2017
• Est. primary completion date: February 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

1. 8 years of age or older

2. Having at least one of the following conditions:

• Keratoconus

• Post-LASIK ectasia

• Pellucid marginal degeneration

• Forme fruste pellucid marginal degeneration

• FFKC

• History of Radial Keratotomy with fluctuating vision.

• Terrien's Marginal Degeneration

3. Signed written informed consent and/or assent

4. Likely to complete all study visits

5. Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

Exclusion Criteria:

1. Severe corneal scarring that markedly affects vision

2. Contraindications to any study medications or their components

3. Pregnancy or breast feeding

4. Active Herpes Corneal Disease

Related Conditions & MeSH terms

• Keratoconus

Intervention

Other:
• Theralight crosslinking and Riboflavin
Corneal Collagen cross linking with UV light and riboflavin

Locations

Country	Name	City	State
United States	Stulting Research Center at Woolfson Eye Institute	Atlanta	Georgia
United States	Talamo Hatch Laser Eye Consultants, LLC	Boston	Massachusetts
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	TLC Laser Eye Center	Fairfax	Virginia
United States	Center for Excellence in Eye Care	Miami	Florida
United States	TLC Laser Eye Center	Rockville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Cxlusa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Best Spectacle Corrected Visual Acuity (BSCVA)		6-9 months
Secondary	Change in Uncorrected Visual Acuity (UCVA)		6-9 months
Secondary	Change in Corneal topography		6-9 months
Secondary	Change in Manifest Refraction		6-9 months
Secondary	Change in Keratometry on topography and Pentacam		6-9 months
Secondary	Change in Wavefront Refraction and aberrations		6-9 months