This question was asked by the FDA Eye Panel which approved laser eye correction in 1996 following an extensive six year research.
In 1996 the FDA approved laser surgery as being both “safe and effective”. I was one of the FDA researchers who performed these very controlled studies for the FDA between 1990 until 2000.
When we started with the research the FDA’s definition of “effective” was that 80% of patients treated during the six year study had to achieve 20/40 vision. Our results were better than what the FDA required from us.
Like any new technology Lasik continued to get better with time and man’s ingenuity. Over the past 18 years Lasik evolved into an ever more successful and safer treatment. See the article “Lasik surpasses contact lenses in safety”. Well performed Lasik by an experienced surgeon on a good candidate is very safe, probably the safest surgery done today. These are undisputed facts in 2008.
A couple of months ago the FDA held hearings on the psychological complaints made by a few patients after undergoing Lasik. These effects were brought to the attention of the FDA by 141 persons who have had surgery in the distant past, in the early days of Lasik. Although the FDA is not accustomed to revisiting an already approved treatment, the FDA accommodated these unhappy people by setting up a meeting and listening to their complaints.
It turns out that there have been 10 million Americans and 16 million people worldwide who have had Lasik and so far only 141 people complained to the FDA, some claiming suicidal tendencies , obviously unrelated to Lasik. 141 out of 16 million people.
Although the FDA panel was impressed by the safety of present-day Lasik the FDA Panel listened to these complaints and recommended that further consideration is ought to be given concerning the quality of life after Lasik. The study which will hopefully reassure the public is to be held in 2009 by the august ASCRS and AAO, the two most prestigious ocular societies.
EDITOR’S NOTE: I see no harm in performing these studies which although are truly unnecessary may will help to reassure the public about the safety of Lasik. 141 out of 16 million lasiks? Pretty safe when done well in my opinion.
Since Lasik is not a product but rather a surgical service the quality of Lasik will vary with the surgeon, the Lasik center and lasers used. So there are degrees of safety and effectiveness. So a statement by me that “Lasik is safe” does not account for poorly done Lasik.
As a general rule, well done Lasik by a skilled Lasik surgeon an a good candidate is quite safe. Statistics show that only one in 10,000 lasiks will have significant a side effect. That is a startling statistic.