Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)

Cxlusa

Status: Terminated

Conditions: Ectasia; Keratoconus; Degeneration

Study type: Observational

Funder types: Industry

Identifiers

NCT01097447

CXL (2)

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: 2,619 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.
• Ability to provide written informed consent
• Likely to complete all study visits
• Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam

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

2,619 participants in 3 patient groups

Ciprofloxicine or Vigamox or other

Description:

up to qid till epithelialized.

Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom

Description:

up to qid for up to 5-10 days postop

Topical steroid (FML, Pred Forte, Flarex

Description:

qid for up to 8 weeks