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

Phase 2

Terminated

• Conditions: Keratoconus
• Interventions: Other: Theralight crosslinking and Riboflavin

• Registration Number: NCT01956474
• Lead Sponsor: Cxlusa

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-09-27
• Study First Submitted QC: 2013-10-04
• Study First Posted: 2013-10-08
• Primary Completion: 2017-02-03
• Study Completion: 2017-02-03
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1324

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Theralight crosslinking and Riboflavin	Theralight crosslinking and Riboflavin	ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin

Primary Outcome Measures

Name	Time	Method
Change in Best Spectacle Corrected Visual Acuity (BSCVA)	6-9 months

Secondary Outcome Measures

Name	Time	Method
Change in Uncorrected Visual Acuity (UCVA)	6-9 months
Change in Corneal topography	6-9 months
Change in Manifest Refraction	6-9 months
Change in Keratometry on topography and Pentacam	6-9 months
Change in Wavefront Refraction and aberrations	6-9 months

Trial Locations

Locations (5)

TLC Laser Eye Center; 🇺🇸 Fairfax, Virginia, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

Stulting Research Center at Woolfson Eye Institute; 🇺🇸 Atlanta, Georgia, United States

Talamo Hatch Laser Eye Consultants, LLC; 🇺🇸 Boston, Massachusetts, United States