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

Cxlusa

Status and phase: Terminated; Phase 2

Conditions: Keratoconus

Treatments: Other: Theralight crosslinking and Riboflavin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01956474

CXL-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,324 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,324 participants in 1 patient group

Theralight crosslinking and Riboflavin

Other group

Description:

ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin

Treatment:

Other: Theralight crosslinking and Riboflavin