Meredith L. Van Tine
University of Virginia School of Law ’10
LASIK (Laser-Assisted In Situ Keratomileusis) is a surgical procedure intended to improve a person’s vision by changing the shape of the cornea and improving the eye’s ability to focus. Other commonly used refractive surgeries include photorefractive keratectomy (PRK), and radial keratotomy (RK).
LASIK surgery permanently changes the shape of the cornea-the clear covering of the front of the eye-through the use of an excimer laser. There are several variations on the surgery, but the most common procedure involves the use of a blade or laser device to cut a flap in the cornea, which is the part of the eye that helps focus light to create an image on the retina. The flap in the newly reshaped cornea is then replaced, although it will never fully stick to the surface of the eye with the same strength that it did before surgery.1
More than 8 million people in the U.S. to date have had vision-corrective LASIK procedures. But, the surgery is not without risks, which include blindness, reduced vision, and a number of other eye injuries. Although a 95% satisfaction rate has been reported, that doesn’t mean that only 5% have had any problems. And, even if we assume that only 5% have serious problems, this would translate into 400,000 people.
Although very safe alternatives exist for most people with vision problems, such as contact lenses and glasses, the FDA has approved lasers used in LASIK surgery that had reported complication rates of more than 20% in the clinical studies used to support their approval applications with the FDA.2 Of the 14 FDA approvals for LASIK lasers, not one single safety and effectiveness study reported adverse events in less than 1% of eyes. And, the clinical trial studies included no long-term follow up, leaving no way to detect late-onset complications, which are an important aspect of safety and effectiveness of these procedures.
In recent years, there has been an effort to encourage the FDA to improve the risk information in the devices’ labeling and to enforce medical device reporting (MDR) requirements at surgical facilities that perform LASIK surgery. In 2008, the FDA held a public hearing to listen to testimony from patients and doctors, including testimony from patients who reported that LASIK surgery left them with blurry vision, double-vision, problems with night vision, and other complications.3 The public testimony also included personal stories of depression, suicide or suicidal ideation, and other psychological problems resulting from adverse LASIK outcomes. In response to this hearing, in September 2008, the FDA updated its LASIK webpage to contain precise definitions of halos, glare, night vision problems, and dry eye as adverse events which should be reported to the FDA.
In 2009, the FDA took further action. In response to concerns about aggressive and often misleading advertising on the part of eye professionals, the FDA issued a cautionary letter indicating that “advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading.”4
Unfortunately, this letter did little to address the claims of advocates that LASIK eye surgery is a leading cause of preventable visual impairment in the United States. Research studies have documented difficulties with night vision and dry eyes, the later of which can be extremely painful.5 One study found that approximately half of the LASIK patients experienced dry eyes within the first week.6 Another study indicated that 20% of LASIK patients had dry eyes for more than 6 months.7
An analysis of FDA Summaries of Safety and Effectiveness for the twelve LASIK lasers approved by the FDA from 1998 through 2004, found that six months after LASIK, 18% of patients reported halos, 20% reported glare, 19% reported night driving problems, and 21% reported dry eyes that were worse, or much worse, than before surgery.8 Other complications have been reported, including infection, inflammation, haze, free caps (where the flap was completely cut off), flap striae (wrinkles), and flap dislocation. A 2008 study by Dr. Jorge Alio and his colleagues from universities in Spain and Turkey, published in the American Journal of Ophthalmology, reported that 28% of the eyes treated with LASIK needed re-treatment within 10 years because of under-correction, over-correction, or regression. The percentage of patients was even higher, since many patients have the problem in one eye: 35%.9
An additional concern is that while the blades used to cut the LASIK flap in a patient’s cornea are only cleared by the FDA for single-use, reports indicate that surgeons often reuse the same blade on the second eye after completion of the first. The medical literature indicates that reuse of blades lowers the quality of the flap-cut in subsequent LASIK procedures. Moreover, tissue on a blade from the first eye can be dragged into, and trapped inside, the second eye. Reports have also circulated of doctors reusing blades on more than one patient-a practice that could easily expose those patients to infection.
Given the severe and potentially life-long nature of many of these complications, it is not surprising that reports have indicated elevated rates of suicide among LASIK patients. For example, in 2008, preliminary findings of an Emory Eye Center study suggested a four-fold increased suicide rate among cornea donors who had LASIK surgery, compared to cornea donors who had not had LASIK.10
Recognizing the profound negative impact that LASIK can have on quality of life, some doctors have revised their post-operative information packets to include language regarding risk of possible psychological damage from an ideal or less-than-ideal LASIK procedure.11
Are patients adequately warned of these risks before deciding to have LASIK surgery? The problems mentioned on the FDA web site and in this article are rarely publicized. And, since LASIK is a relatively new procedure (first approved in the United States in 1998), very little long-term data even exist to be made available to the public.
If you are considering LASIK surgery, carefully read about the risks and likely benefits before you make a decision. For example, women and patients requiring higher refractive correction are at an increased risk of developing dry eye after LASIK surgery, which can be a chronic and very painful condition.7 Also, since LASIK is a costly procedure, farsighted patients should know that gains in vision from LASIK may be lost with age. Individuals who use reading glasses prior to getting LASIK should be aware that they may still need them after surgery. Be sure to thoroughly investigate your options, and read the informational materials on the FDA website (quoted in part below). If you decide to proceed with the surgery, make sure that you do careful research before selecting a doctor to perform the procedure.
The FDA counsels patients considering any sort of refractive eye-surgery, including LASIK, with the following information (available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm061366.htm).
The FDA explains that you are not a good candidate for refractive surgery if:
- You are not a risk taker
- Vision problems could jeopardize your career
- Cost is an issue: the surgery costs several thousand dollars per eye and is not covered by most health insurers
- You required a change in your contact lens or glasses prescription in the past year
- You have a disease or are on medications that may affect wound healing
- You actively participate in contact sports
- You are not an adult
Other risk factors:
- Blepharitis (inflammation of the eyelids)
- Large pupils
- Thin corneas
- Previous refractive surgery of any type (e.g., RK, PRK, LASIK)
- Dry eyes
1. “Your corneal flap will never adhere to the surface of the eye with quite the same strength it did prior to the surgery, so there is a rare but possible risk of the flap becoming displaced with sufficient force.” Source: October, 2008 publication of the American Academy of Ophthalmology (AAO), International Society of Refractive Surgery (ISRS), and Opthalmic Mutual Insurance Company (OMIC) titled “Is LASIK For Me? A Patient’s Guide to Refractive Surgery” located online at http://www.geteyesmart.org/correction/upload/LASIK_guide.pdf.
2. Lauranell H. Burch, Ph.D. letter to Government Accountability Office (GAO) and the HHS Inspector General (June 11, 2009) available at http://www.lasiknewswire.com/Ltr-GAO-11Jun09.pdf.
3. FDA, 110th Meeting of the Medical Devices Advisory Committee, “Summary Minutes, Medical Devices Advisory Committee” April 25, 2008, available at http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4353m1.htm.
4. Food and Drug Administration, Center for Devices and Radiological Health, “FDA Letter to Eye Care Professionals” (May 22, 2009) available at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/ucm154882.htm.
10. Sabine Vollmer, “Some link depression, failed LASIK.” (February 3, 2008, The News Observer) available at http://www.newsobserver.com/150/story/920341.html.
11. Ocular Surgery News, “Surgeon Shares Refractive Surgery Trends in Clinic in Australia” (May 18, 2009) available at http://www.osnsupersite.com/view.aspx?rid=40013.
Additional LASIK information: