Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas

Cxlusa

Status: Terminated

Conditions: Ectasia; Keratoconus; Degeneration

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01189864

CXL (12 & older)

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. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.

Enrollment: 3,493 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 12 years of age or older
• Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD).
• Diagnosis of FFKC
• History of Radial Keratotomy with fluctuating vision
• Ability to provide written informed consent
• Likely to complete all study visits
• Minimum corneal thickness of at least 300 Measured by ultrasound or Pentacam
• At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)

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

3,493 participants in 3 patient groups

Ciprofloxicin or Vigamox or other.

Treatment:

Drug: Ciprofloxicin or Vigamox or other.

Nonsteroidal (Acular, Voltaren Xibrom, etc)

Treatment:

Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)

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

Treatment:

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