Dissatisfaction reported by some patients who underwent LASIK procedures has attracted the attention of U.S officials. 

Advocates have warned surgeons to improve their follow up routines so that complications may be reduced. A study by the FDA has been initiated to address the unfulfilled expectations of patients. The Food and Drug Administration announced in Oct. 2009, that seventeen LASIK centers were discovered to have inadequate systems to reveal complications following the surgery. Most centers stated that the process to enhance and improve existing procedures will start immediately. 

The study will involve participation with the National Eye Institute and the Department of Defense to gather the necessary material for the study. The agency's Center for Devices and Radiological Health maintains that it will continue its inspections and insists that LASIK centers should maintain excellent records as mandated by law. Negative results will be studied by the FDA to better understand and subsequently to take the necessary action to ensure safety and efficiency requirements. Many facilities had no system for collecting and transmitting adverse results to the FDA. The first segment of the investigation started in July 2009 wherein online questionnaires were presented. The second portion will pursue reports from military treated at the Navy Refractive Surgery Center. The final portion of the study will concern the general population and should be completed in 2012. 

It has been estimated that more than 14 million people in the U.S. have availed themselves of the LASIK procedure, hoping to improve their vision. Eye centers were amassing over a million surgeries each year, before the economic decline last year. Aggressive marketing has made it a $2 billion dollar industry. Doctors weigh the success of millions against several hundred unhappy patients and feel that there is a plus value there. Doctors have been criticized for overselling the benefits and underplaying the risks. 

However, a California ophthalmologist said that he considered LASIK to be safe and effective for the large majority of patients but recognized that it carries risks just like any medical procedure. The most frequent complication, he revealed, lies with infection, but equipment related problems are rare. Another common complaint is from halos, glare and reflections during night time driving. The doctor said that LASIK is probably one of the most common elective procedures ever pursued. The procedure was approved in 1995 to correct normal refractive errors correctible through corneal alterations. However, presbyopia requires the use of an additional reading prescription to fulfill near vision tasks. Those patients who thought that they could discard their glasses forever will be severely disappointed. 

Barbara Berney is the president of the Vision Surgery Rehab Network. This organization serves patients who wish to find other doctors who can rectify procedures that have gone wrong. In 2001 Ms. Berney had LASIK surgery performed, which was unsuccessful and left her with vision which prevents her from night driving and reasonable comfort in the presence of fluorescent lighting. She is a patient representative to the FDA panel that will investigate the facts concerning the planned quality of life study. Another pressure group was organized by Ron Link and Margaret Dolan as a result of negative consequence following their LASIK surgery. Their website is www.surgicaleyes.org. 

Announcement of the FDA study was first made during an agency hearing in April, 2009 since many patients reported their ill after effects resulting from LASIK surgery. Briefly, the surgeons slice a very thin flap from the cornea and then alter its shape and consistency in a procedure that takes about 15 minutes for each eye. Flattening the cornea using computerized measurements neutralizes myopia, while changing the corneal stroma to steepen the cornea counteracts hyperopia. The surgeon can change refractive errors due to astigmatism by affecting areas corresponding to the axis of the cylinder created by the uneven curvatures of the cornea. 

According to Barbara Berney and Ron Link, major risks associated with unsuccessful LASIK treatment might include partial loss of vision, monocular double vision, dry eye syndrome, glare, halos, difficulty in night driving and occasional fluctuation of vision. Severe side issues have been reported, such as: lost jobs, broken marriages, people relying on antidepressants and even attempted suicides.

LASIK has not been approved for the correction of presbyopia, the natural aging process that limits the conventional use of refractive corneal surgery. This aging process cannot be reversed by LASIK surgery. Bifocals, multifocal contact lenses and reading glasses are the methods that are commonly used to handle presbyopia. Patients question the practicality of the surgery when they understood that there will be a need for near vision correction in the future. 

The American Society of Cataract and Refractive Surgery feels that perhaps as many as 5 percent of the patients are not happy with the results. Some dissatisfied consumers have felt that the figure is too low and, as we have noted, set up websites to espouse their cause. It has been discovered by investigators that high myopia may not be accurately corrected at first and "adjustment" surgery may follow to better the results of the original surgery. There is no guarantee that the follow up surgery will produce the goal of 20/20 vision.

While thick corrective spectacle lenses will be drastically reduced, the condition may still require spectacles to reach the desired vision expected. A certain percentage of patients will achieve 20/20 vision immediately following the surgery. Those who report sensitivity to light or glare will seek anti-glare tints and sunglasses, day or night as needed, to alleviate their symptoms. It may take three to six months for the vision to stabilize following the surgery. A temporary prescription may be useful during this period of time. Common sense demands that contact sports should be avoided for a couple of months. The surgeons recognize their responsibility to offer full disclosure as to the adverse effects as well as the benefits of the LASIK procedure. 

For example, a thorough initial assessment visit is suggested to eliminate pre-existing conditions that would contra indicate the surgery. The procedure is not recommended for patients under 18 years of age, in cases of pregnancy, history of corneal problems, pupil size larger than 7 mm, and very thin corneas. Also, ophthalmologists lament that the long term results are not yet known. A significant number of eye care professionals profess that since the surgery is not guaranteed, and the expense is great, perhaps affordable spectacles may be more of a certainty and an easier path to pursue. Just follow that old saw, “Look before you leap."

Here are a few tips to help you select a good doctor:

1. Don't choose a doctor whose nick-name is "Chug a Lug". (Jeff Foxworthy)

2. Never go to a doctor whose office plants have died. (Erma Bombeck)

3. Be careful when you go into the optometrist's office. When you open the door and say to the receptionist, "I think I need my eyes checked." She may say, "You're not kidding. This is the ladies room."

Elmer Friedman, O.D.
elmerf@verizon.net