05 | 3 | 2008 Posted By Regan Zambri & Long

FDA Website: LASIK Surgery Risks and Patient Education

Laser eye surgeries such as LASIK (Laser-Assisted In Situ Keratomileusis) are quickly becoming some of the most common and technologically sophisticated procedures available for correcting relatively minor vision problems.  Generally performed on an out-patient basis with the aid of only anesthetic eye drops, LASIK procedures are usually quick and easy, and the results are often remarkable.  Unfortunately, however, the results can be underwhelming, too -- and occasionally even catastrophic. 

To help clear up some misconceptions and misinformation regarding LASIK procedures, and to help consumers better understand the risks of laser eye surgeries, the U.S. Food and Drug Administration (FDA) has established a web page devoted specifically to patient education.  According to the agency, there are a few categories of people who should think twice before they attempt to resolve their vision problems with LASIK surgery.

According to the agency, you are probably NOT a good candidate for LASIK surgery if:

  • "You are not a risk taker:  Certain complications are unavoidable in a percentage of patients, and there are no long-term data available for current procedures.
  • It will jeopardize your career:  Some jobs prohibit certain refractive procedures. Be sure to check with your employer/professional society/military service before undergoing any procedure.
  • Cost is an issue:  Most medical insurance will not pay for refractive surgery. Although the cost is coming down, it is still significant.
  • You required a change in your contact lens or glasses prescription in the past year:  This is called refractive instability. Patients who are:

  • In their early 20s or younger, 
  • Whose hormones are fluctuating due to disease such as diabetes,
  • Who are pregnant or breastfeeding, or 
  • Who are taking medications that may cause fluctuations in vision, 

are more likely to have refractive instability and should discuss the possible additional risks with their doctor.

  • You have a disease or are on medications that may affect wound healing:  Certain conditions, such as autoimmune diseases (e.g., lupus, rheumatoid arthritis), immunodeficiency states (e.g., HIV) and diabetes, and some medications (e.g., retinoic acid and steroids) may prevent proper healing after a refractive procedure.
  • You actively participate in contact sports:  You participate in boxing, wrestling, martial arts or other activities in which blows to the face and eyes are a normal occurrence.
  • You are not an adult:   Currently, no lasers are approved for LASIK on persons under the age of 18."

Other risk factors:
Your doctor should screen you for the following conditions prior to LASIK surgery.

  • "Blepharitis. Inflammation of the eyelids with crusting of the eyelashes, that may increase the risk of infection or inflammation of the cornea after LASIK.
     
  • Large pupils. Make sure this evaluation is done in a dark room. Although anyone may have large pupils, younger patients and patients on certain medications may be particularly prone to having large pupils under dim lighting conditions. This can cause symptoms such as glare, halos, starbursts, and ghost images (double vision) after surgery. In some patients these symptoms may be debilitating. For example, a patient may no longer be able to drive a car at night or in certain weather conditions, such as fog.
  • Thin Corneas. The cornea is the thin clear covering of the eye that is over the iris, the colored part of the eye. Most refractive procedures change the eye’s focusing power by reshaping the cornea (for example, by removing tissue).  Performing a refractive procedure on a cornea that is too thin may result in blinding complications.
  • Previous refractive surgery (e.g., RK, PRK, LASIK).  Additional refractive surgery may not be recommended.  The decision to have additional refractive surgery must be made in consultation with your doctor after careful consideration of your unique situation.
  • Dry Eyes. LASIK surgery tends to aggravate this condition."

Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:

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