Corneal Crosslinking get long awaited FDA approval

The Delray Eye Associates are proud to report that after serving as Clinical Investigators for AVEDRO’s FDA trial on Corneal Crosslinking for Keratoconus for the past two years, the FDA has recently approved this revolutionary new procedure.

Corneal crosslinking was originally developed in Germany and has spread throughout the world over the past ten years. The long international experience with corneal crosslinking has easily demonstrated the safety and efficacy of this procedure for the treatment of keratoconus. It has taken the FDA a very long time to finally approve this beneficial procedure here in the United States, and they have only approved one company’s crosslinking device and riboflavin drops which are manufactured by AVEDRO.

Keratoconus is a relatively common inherited disease of the cornea, the clear front window of the eye. In this disease, usually starting in one’s teens or twenties, the cornea starts to lose it structural integrity, becomes abnormally thin, starts to bulge and causes significant astigmatism. Astigmatism is an irregular corneal surface or contour. Initially, one may need eyeglasses with significant astigmatism correction, but in many cases the condition progresses to the point where only hard contact lenses can adequately correct the vision. In very advanced cases, one can longer be fit with contact lenses and a traditional corneal transplant must be performed to regain one’s vision.

AVEDRO’s FDA approved corneal crosslinking procedure is performed in the sterile treatment room in our office, using only topical anesthetic eye drops, and takes about one hour. We treat one eye at a time to allow for proper healing before deciding to proceed with treating the second eye, as healing may take weeks to months. The corneal surface is prepared and then riboflavin eye drops are administered to the eye, followed by treatment with the AVEDRO corneal crosslinking ultraviolet light device. The treatment increases the microscopic bonds between the hundreds of collagen fibers that make up our clear cornea, so the cornea is strengthened and will not continue to bulge and get thinner. In fact, many cases experience reduction in the astigmatism of the corneal surface and also have improved vision both with and without glasses (although this result can’t be guaranteed in all cases).

The younger a patient is when the keratoconus is diagnosed, the greater is the long term risk for developing more advanced disease and greater loss of vision. Thus treating patients sooner, rather than later, is usually of benefit to prevent significant progression of the keratoconus.

For more information on keratoconus and treatment options, including collagen crosslinking, go to http://www.nkcf.org

If you would like a consultation to determine if you are a candidate for this revolutionary, sight saving procedure, please contact our office and ask for Ellen Salvati, our Surgical Coordinator.