Want more CXL information?

posted Jul 14, 2012, 12:03 PM by Jen Weigel   [ updated Aug 9, 2012, 5:55 PM ]
If you want more CXL information, there are two good websites that can provide what you're looking for:

Avedro's company website summarizes what they are doing to help patients with ectasia.  According to Avedro, they are the world leader in corneal cross-linking science.

The National Institutes of Health provides a summary of all FDA studies, including this upcoming CXL study.  Visit this link to learn more about the study's details, including a list of inclusion and exclusion criteria.

To highlight some important points, as taken directly from the NIH website mentioned above:

Official study name:  A Multi-Center, Randomized, Controlled Evaluation of the Safety and Efficacy of the KXL System with VibeX (Riboflavin Ophthalmic Solution) for Corneal Cross-Linking in Eyes with KCN or Corneal Ectasia after Refractive Surgery
   
    NOTE:  Drs. Holzman and Solomon will be enrolling KCN patients only into this study.

Official study objective:  To evaluate and compare the safety and efficacy of
three treatment regimens for corneal collagen cross-linking performed with VibeX (Ribofavin Ophthalmic Solution) and the KXL System for reducing corneal curvature.

Inclusion and exclusion criteria, as shown on the NIH website:

Inclusion Criteria (all subjects):

  • be at least 12 years of age
  • provide written informed consent
  • Willingness and ability to follow all instructions and comply with schedule for follow-up visits
  • For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the first visit and for one month after the last dose of investigational product.
  • Best Spectacle Corrected Visual Acuity (BSCVA) of less than or equal to 80 letters on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
  • Presence of central or inferior steepening

  • Contact Lens Wearers Only:

    1. Removal of contact lenses for a required period of time prior to the screening refraction
    2. manifest refraction must be stable between two visits which occur at least 7 days apart
  • Having a diagnosis of mild, moderate or severe keratoconus
  • Steepest keratometry (Kmax) value ≥ 47.00 D

Exclusion Criteria:

  • Contraindications or sensitivity or known allergy to the use of the test article(s) or their components
  • If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to randomization or during the course of the study
  • Corneal pachymetry that is < 375 microns prior to epithelial debridement at the thinnest point in the eye to be treated
  • Eyes which are aphakic
  • Eyes which are pseudophakic and do not have a ultraviolet blocking lens implanted;
  • Eyes that have the maximum corneal curvature (Kmax) outside of the 5mm zone
  • Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications.
  • A history of delayed epithelial healing in the eye(s) to be treated
  • Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
  • Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
  • Taking Vitamin C supplements within 1 week of the cross-linking treatment
  • History of previous cross-linking treatment in the eye to be treated
  • Have used an investigational drug or device or be concurrently enrolled in another investigational drug or device trial within 30 days of the study
  • A history of previous Limbal Relaxing Incision procedure in the eye(s) treated
  • Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
  • A history of previous corneal surgery or the insertion of Intacs in the eye to be treated. - jw

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