Alternatives of Lasik Eye Surgery?
Every patient considering Lasik Eye Surgery needs an objective understanding of alternatives when considering Lasik Surgery so as not to get caught up in the "latest and greatest" fad that may be sweeping the Lasik Eye Surgery community today.
There are numerous facts that potential Lasik patients should consider as they may consider evaluating alternatives to Lasik Eye Surgery.
Lasik Alternatives cont..
Lasik Eye Surgery was used first in 1989 performed internationally then introduced to United States Lasik eye surgeons in 1990. Lasik Eye Surgery underwent extensive clinical trials by the Food and Drug Administration to demonstrate safety and predictability. The FDA approved lasik eye surgery in 1998 from the data provided. Most eye care consumers don't realize there are two paths to gain the FDA's approval. One, the PMA approval process, is extensive, time consuming and approximates how a device or procedure will perform in the "real world" in terms of safety. The second route the 510(k) Approval is simply a manufacturerer demonstrating a limited amount of safety data in order to obtain approval. Sometimes devices such as surgical instruments can be FDA approved with little or no clinical trials under the 510(k) process.
This means that Lasik EYe Surgery perfomed with the Excimer Laser has had extensive FDA personel monitoring clinical testing. Other "new devices" introduced to outperform Lasik Eye may have not undergone the same level of testing and scrutiny as Lasik Eye Surgery to make sure that it was as safe and effective. The first several thousands of patients treated with these new devices could literally be the clinical trials where the device manufacturers will use results on these people to refine their devices and make them more effective.