The most promising technology for treating Keratoconus called collagen cross linking (CXL) with UVA is currently being introduced into the United States under experimental protocols in Clinical Trials. This treatment, which has been used in Europe for eight years, now is undergoing Phase 1 FDA clinical trials in the United States. It has been demonstrated to be safe and effective if performed, with the epithelium removed, and has the potential to stop the progression of Keratoconus. This treatment is recommended for individuals with progressive Keratoconus or Ectasia following LASIK to stabilize the cornea. It can be performed with our without INTACS. Even though enrollment for this procedure for the FDA trials is closed, our center is one of the only centers in the United States that has received and I.D.E. (Investigational Device Exemption) from the FDA to treat patients with this procedure and we are currently enrolling patients under an Investigational protocol.
This protocol allows us to enroll patients for the next 5 years and can be viewed on the government website – www.clinicaltrials.gov. Since this treatment is still regarded as experimental in the United States it should only be done with Institutional Review Board (IRB) approval, so that patients can adequately be protected.
The procedure, which is painless, is as follows. The top layer of the cornea is removed under local anesthesia. Vitamin drops are soaked into the cornea until they penetrate the entire corneal and evidence of penetration into the anterior chamber of the eye is demonstrated by slit-lamp evaluation. Once this is confirmed the patient’s eye is put under a specialized lamp, which emits UV light at a predetermined wavelength for approximately 30 minutes. During this process the cross links, which link the fibers of the cornea, are increased thereby stiffening the whole cornea. A bandage contact lens is then put on the eye and patients are given antibiotics and anti-inflammatory drops and follow up on a regular basis with their physicians for several months. Many patients notice an improvement in their vision at 3 to 6 months and European studies suggest that only 5-8% of patients need to be retreated.
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