Avedro receives CE mark approval (similar to FDA approval) for Advanced Corneal Cross-Linking System for Photorefractive Instrastromal Cross Linking Corneal cross linking is a technique in which ultra-violet light and riboflavin (a B vitamin) are applied to the cornea to make it stiffer and stronger. It currently is in FDA clinical trials in the United States for use in treating a genetic disease of the cornea called keratoconus. In keratoconus, the collagen substance of the cornea is weaker than normal and the cornea has trouble maintaining its shape over time. Keratoconus is a contra-indication for having LASIK.
Corneal cross linking attempts to counter corneal weakness seen in keratoconus by actually making the cornea stronger and more able to maintain its shape. The preliminary data from the US FDA clinical trials is quite encouraging and I feel that this will soon be a routinely performed treatment for those patients with keratoconus. While these patients still should not have LASIK, it appears that they can have PRK laser vision correction surgery after corneal cross linking in order to improve vision without glasses or contacts.
Avedro is one of the manufacturers of corneal cross linking machines that is currently in the process of undergoing FDA clinical trials. They have developed a new unit that allows for faster, or “accelerated” cross linking treatments. In Europe, Avedro received CE mark approval — which is their rough equivalent to FDA approval here — for advanced cross linking using a procedure called photorefractive intrastromal cross linking, or PiXL. This is an exciting development which we hopefully will soon be able to offer our patients here in the United States.
See Also
US Corneal Cross Linking Study
National Keratoconus Foundation summary of US clinical trials for corneal collagen cross linking.
Corneal Collagen Crosslinking for Keratoconus and LASIK Complications
All About Vision summary of corneal collagen cross linking for keratoconus and LASIK complications
Cross-linking: Asking the Tough Questions
A Review of Ophthalmology summary article about some potential downsides of of corneal crosslinking.
Keratoconus Causes, Symptoms, and Treatments
All About Vision review of keratoconus, a genetic disease of the cornea.
Photorefractive Intrastromal Corneal Cross Linking
Avedro’s discussion of photorefrative intrastromal corneal cross linking (PiXL).
Avedro Announces CE Mark Clearance for its KXL II Advanced Cross Linking System
Avedro received CE Mark Clearance in Europe for using its advanced cross linking system to perform PiXL.