As you know, keratoconus is a progressive disease with limited treatment options, but corneal collagen crosslinking (CXL) is emerging as a potential new way to strengthen and stabilize the cornea and enable patients to avoid surgery. Numerous studies conducted around the world have shown CXL to be safe and effective. Originally developed in Dresden, Germany in the 1990s, the procedure has been cleared for use in Europe, and medical device and pharmaceutical company Avedro is working toward approval in the United States. The FDA has granted orphan drug designation for the company’s VibeX 0.1% riboflavin solution, which is used with its KXL System for ultraviolet-A (UVA) irradiation, for corneal crosslinking to treat keratoconus as well as corneal ectasia following refractive surgery.
Barnet Dulaney Perkins Eye Center is pleased to announce that we are a study site for a new multi-center, randomized, controlled trial using Avedro’s VibeX and KXL System. We are happy to evaluate any patient you may wish to refer to us for participation in the study. Patients must be at least 12 years old, and the cost to each patient is $1,250 per eye.
The study is evaluating three treatment protocols for accelerated crosslinking, which is designed to significantly reduce the duration of the procedure. Patients in the study are randomized to one of three treatment groups: UVA irradiation for 8 minutes at 15 mW/cm2, UVA irradiation for 4 minutes at 30 mW/cm2, or UVA irradiation for 2 minutes 40 seconds at 45 mW/cm2. Key inclusion and exclusion criteria are as follows.
Inclusion Criteria for Keratoconus
- Maximum corneal curvature as measured by Kmax of ≥47.00D
- Topographic evidence of keratoconus diagnosed as mild (axial topography consistent with keratoconus; flat keratometry reading ≤51.00D on topography map), moderate (axial topography consistent with keratoconus; flat keratometry reading ≥51.01D and ≤ 56.00D or astigmatism ≥8.00D on topography map), or severe (axial topography consistent with keratoconus with marked areas of steepening; flat keratometry reading ≥56.01D on topography map)
Inclusion criteria (corneal ectasia patients only)
- Diagnosis of corneal ectasia after refractive surgery; axial topography consistent with ectasia
Exclusion criteria (all patients)
- Corneal pachymetry that is
- Eyes that are aphakic
- Eyes that are pseudophakic and do not have a UV-blocking lens implanted
- Eyes that have the maximum corneal curvature (Kmax), as identified and measured by topography, outside of the central 5-mm zone
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose it to future complications, e.g., history of corneal disease such as herpes zoster keratitis, recurrent erosion syndrome, corneal dystrophy, etc.
- History of delayed epithelial healing in the eye(s) to be treated
- Current condition that, in the investigator’s opinion, would interfere with or prolong epithelial healing
- Previous corneal crosslinking treatment in the eye(s) to be treated
- Previous limbal relaxing incision in the eye(s) to be treated
Exclusion criteria (keratoconus patients only)
- Eyes classified as either normal, atypical normal or keratoconus suspect on the severity grading scheme
- History of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated
The full name of the study is “A Multi-Center, Randomized, Controlled Evaluation of the Safety and Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery. More information about the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01459679?term=crosslinking&rank=48.