Clinical trial NCT01956474: CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Official title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Keratoconus
Keywords: keratoconus
cross-linking
Post-LASIK ectasia
Pellucid marginal degeneration
Forme fruste pellucid marginal degeneration
FFKC
Radial Keratotomy
Terrien's Marginal Degeneration
Lead sponsor: Cxlusa
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 1324
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Best Spectacle Corrected Visual Acuity (BSCVA)
timeFrame: 6-9 months
Secondary outcomes:
measure: Change in Uncorrected Visual Acuity (UCVA)
timeFrame: 6-9 months
measure: Change in Corneal topography
timeFrame: 6-9 months
measure: Change in Manifest Refraction
timeFrame: 6-9 months
measure: Change in Keratometry on topography and Pentacam
timeFrame: 6-9 months
measure: Change in Wavefront Refraction and aberrations
timeFrame: 6-9 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
city: Atlanta
country: United States
facility: Stulting Research Center at Woolfson Eye Institute
state: Georgia
city: Rockville
country: United States
facility: TLC Laser Eye Center
state: Maryland
city: Boston
country: United States
facility: Talamo Hatch Laser Eye Consultants, LLC
state: Massachusetts
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Fairfax
country: United States
facility: TLC Laser Eye Center
state: Virginia
Study officials:
affiliation: Cxlusa
name: William Trattler, MD
role: PRINCIPAL_INVESTIGATOR
References: