Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Cxlusa

Status: Terminated

Conditions: Ectasia; Keratoconus; Degeneration

Treatments: Drug: Steroid (FML, Pred Forte, Flarex, etc.); Drug: Ciprofloxicine or Vigamox or other.; Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc)

Study type: Observational

Funder types: Industry

Identifiers

NCT01024322

CXL

Details and patient eligibility

About

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. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication

Enrollment: 1,189 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 8 years of age or older
• Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
• Diagnosis of FFKC
• History of Radial Keratotomy with fluctuating vision.
• Terrien's Marginal Degeneration
• Ability to provide written informed consent
• Likely to complete all study visits
• Minimum corneal thickness of at least 300 250 microns measured by ultrasound or Pentacam for all indications other than Terriens. For Terriens, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

Exclusion criteria

• Severe corneal scarring that markedly affects vision
• Contraindications to any study medications or their components
• Pregnancy or breast feeding
• Active Herpes Corneal Disease

Trial design

1,189 participants in 3 patient groups

Ciprofloxicine or Vigamox or other.

Treatment:

Drug: Ciprofloxicine or Vigamox or other.

Nonsteroidal (Acular, Voltaren Xibrom, etc)

Treatment:

Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc)

Steroid (FML, Pred Forte, Flarex, etc.)

Treatment:

Drug: Steroid (FML, Pred Forte, Flarex, etc.)