FDA permits Swiss attempt to study benefits of CXL

In a first research of its kind, the Swiss-based Peschke Meditrade GmbH has initiated a investigation to study the benefits of corneal collagen cross-linking (CXL) in subjects with progressive keratoconus and corneal ectasia after prior refractive surgery. 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.

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.

So far, FDA has permitted 160 patients into each study. 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.

Source: Medical News Today


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