US FDA Launches LASIK Study

by Gopalan on  October 19, 2009 at 3:58 PM General Health News
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 US FDA Launches LASIK Study
The U.S. Food and Drug Administration has announced the launch of a study to assess the problems faced by patients after LASIK surgery.

The Laser-Assisted In Situ Keratomileusis (LASIK) is a surgical procedure that uses an eximer laser to permanently change the shape of the cornea, but there have been complaints of pain and discomfort from a number of patients. And hence the study  called the LASIK Quality of Life Collaboration Project, in which the FDA will be working with the National Eye Institute and the U.S. Department of Defense.

Funded by the government agencies, the project is composed of three phases. The objective of Phase 1, which began in July 2009, is to design and implement a Web‑based questionnaire to assess patient-reported outcomes and evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure.

Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center.

Phase 3 will be a national, multi-center clinical trial and will study the impact of the procedure on quality of life following LASIK in the general population. Patient enrollment in Phases 2 and 3 have yet to begin but plans are underway. Phase 3 is expected to end in 2012.

The results of the project will help identify factors that can affect quality of life following LASIK and potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors are related to the safety or effectiveness of the lasers used in LASIK surgery, the FDA will evaluate whether any action is necessary. The project is part of the FDA's ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

"This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure," said Dr. Jeffrey Shuren, acting director of the FDA's Center for Devices and Radiological Health.

The FDA also announced that it issued warning letters to 17 LASIK ambulatory surgical centers after inspections revealed inadequate adverse event reporting systems at all the centers. The inspections did not identify problems with the use of the LASIK devices at these facilities.

Under legislation passed in 1990, user facilities, which include nursing homes, outpatient clinics and ambulatory surgical centers, must report device-related deaths to the FDA and to the device manufacturer. They also must report device-related serious injuries to the manufacturer or to the FDA if the manufacturer is not known. Requirements include having a written protocol for adverse event reporting.

The FDA inspected ambulatory surgical facilities that perform LASIK over the past several months and additional inspections are pending. The FDA regulates ophthalmic lasers used in LASIK, including monitoring their continued safety and effectiveness by analyzing reports on their post-market use, it has been stated on its website.

"Many people in the U.S. undergo LASIK procedures," said Shuren. "Ambulatory surgical centers that perform LASIK must maintain a robust reporting system as required by law. Reporting adverse events to the FDA is critical to better understand the safety and effectiveness of ophthalmic lasers used in LASIK procedures and to enable the FDA to take appropriate actions where the lasers do not meet safety and effectiveness requirements."

Source: Medindia

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I had Lasik Eye Surgery in 1999. I have to say I do not remember them cutting into my eyes. I don't know why...I probably would have freaked out if they had but what I remember is that they put on the clamp told me to sit still and proceeded with the laser for quite a few seconds. They did the same in the other eye. Then I was sent home with two different types of drops. I did feel that my eyes were more dry and felt like I could never rub my eyes because it felt weird and even hurt a little bit. The good thing is that I did enjoy a 20/20 vision for quite sometime but it wasn't meant to last I guess because after nine years my vision started to go bad again. Slowly but surely...It's been going bad for the last three years...since 2008. I have been wearing glasses since 2009 officially...When it started to go bad I refused to accept it and did not want to wear glasses but by the second year I didn't have a choice...Now it's as bad as it was before the surgery and when I spoke to my doctor about it he just said: "Well statistics show that the surgery lasts forever for some people and not for others"...After paying $2,800.00 for the surgery it doesn't make me feel better to know that...The doctor says that he could do another correction for a smaller fee...Y'a right! At this point I'm to scared that something could go wrong and also I have lost all trust in this type of surgery...I'm glad for the people for who the surgery worked out fine and and is forever lasting but I wanted to let people out there know that it does not work or last for everybody...Sorry for the long comment...I just a lot to say about this...


My experience: 44 year old male with diabetes. The doctor told me that I would probably need reading glasses. I thought (stupidly) that everytime I would read a book I would need reading glasses. Instead everytime I look at small print, I need reading glasses and it sucks. During the healing process severe pain and discomfort for three months. I still have complaints of eye hurting when sleeping and first waking up (a little over a year post op). Something about tear production and certain nerves being cut in the process. To top it all off the facility that did the procedure changed doctors on me three times. If I would have known that the doctor would not be there till the end I would not have had it done with him and that national chain. A year post op and some days my vision better than others and some days my eyes drier than others. I think there also needs to be some research for patients with diabetes. I do not know what the future will hold.


I had the lasik procedure done in 2006 after I returned home from Iraq. Everything was great for a year or so. I could see far better than I had with glasses. Then about, 2007-2008, my vision slowly started to decline. Now in 2009, my vision had declined so far, I have had to start wearing a special contact that helps hold the shape of my cornea. When the procedure was done, my cornea was cut so thin, that now it is flimsy and doesn't hold shape. Lasik has been a complete waste of money for me and will eventually cost me more money than a lifetime of glasses would have.


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