As we learn more about how to treat eye conditions, disorders and diseases, new technology and procedures are developed.  Eye care technology continues to advance very quickly and patients require an objective understanding of other choices to avoid getting caught up in the newest trend.  LASIK clients should consider a number of things when looking at LASIK other choices.

LASIK has a Long, Well-Documented History of Success.
LASIK was originally performed internationally in 1989 before being introduced to LASIK Surgeons in the United States in 1990.  LASIK was subjected to Food and Drug Administration clinical trials to prove its safety, efficacy and predictability in the early 1990’s before being approved in 1998 from the data provided as part of a Pre-market Approval Application (PMA).  Patients need to be aware of the two processes leading to FDA approval. 

The PMA approval process is thorough, lengthy and demonstrates how a device or procedure will perform with regards to safety and efficacy in the real world. There is another route available call the 510(k) Approval that requires the manufacturer to provide only a limited amount of safety data to receive approval.

What Does This Mean?
LASIK Eye Surgery performed with the Excimer Laser has been tested and analyzed thoroughly, to a higher degree than is required for many new devices to obtain FDA approval.  Devices approved through the 5109(k) approval process may be performing their clinical trials on the patients being treated to learn how they can make their equipment more effective.  LASIK has already been proven.