Study evaluates corneal collagen cross-linking in subjects with progressive keratoconus

Nov 26 2008

Presently keratoconus is treated through eyeglasses, hard contact lenses, and a newer treatment, INTACS plastic rings inserted into the mid layer of the cornea to flatten it, changing the shape and location of the cone.

In 15-20% of the cases, cornea transplant surgery is necessary. The Cornea Research Foundation of America is one of 9 sites in the U.S. currently participating in a new clinical research investigation to study the benefits of corneal collagen cross-linking (CXL) in subjects with progressive keratoconus and corneal ectasia after prior refractive surgery. These studies are the first in the U.S. of CXL designed to assess the safety and effectiveness of CXL for slowing the progression of both of these conditions.

"Because the FDA usually requires data from two separate studies before approving a new drug or device, we are conducting two cross-linking studies: one is for the treatment of keratoconus and the other is for treatment of post-refractive ectasia, a rare complication of refractive surgery," says Marianne Price, executive director of the Cornea Research Foundation of America.

The FDA permitted study is sponsored by Swiss-based Peschke Meditrade GmbH. Corneal collagen cross-linking is a procedure that involves administering riboflavin and UVA in carefully selected parameters that strengthen the front layers of the cornea and avoid damage to the back of the eye. The riboflavin and UVA light source that is used for CXL are both investigational in the United States and are not yet approved by the FDA.

The Foundation started the collagen cross-linking study in January 2008. The FDA has given permission for enrollment of 160 patients into each study. People interested in more information about the study or participating in the study can contact the Cornea Research Foundation of America. Subjects may be eligible for the study if they have the following in one or both eyes, or are:

• 18 years of age or older
• Have been diagnosed with progressive keratoconus or have had previous vision correction surgery and now have corneal ectasia
• Vision with contact lenses or glasses is worse than 20/20
• Corneal thickness greater than 300 microns at the thinnest point
• If you are female, you cannot be pregnant
• Can leave contact lenses out for at least 3 months in the eye to be treated
• If you have keratoconus, you cannot have had previous corneal surgery or Intacs
• If you have keratoconus, it must have gotten worse in the last two years based on your previous eye exams. You will need to contact your eye doctor or allow us to contact your eye doctor to get your eye exam records for your vision measurements, corneal maps (topography) and contact lens or glasses prescriptions.

Expert Source: Dr. Marianne Price, executive director of the Cornea Research Foundation of America. Dr. Price is a sought after speaker and published author, a member of the American Academy of Ophthalmology, the Association for Research in Vision and Ophthalmology, the American Society of Cataract & Refractive Surgery, and Ophthalmic Women Leaders. Dr. Price holds a bachelor's degree in engineering science from the University of Notre Dame and both an MBA in finance and a doctorate in medical and molecular genetics from Indiana University.