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Sunday / June 23.
HomemiophthalmologyFDA Launches LASIK Review

FDA Launches LASIK Review

After years of consumer complaints, the U.S. Food and Drug Administration (FDA) is launching a three-stage study of consumer satisfaction with laser vision correction. The LASIK Quality of Life Collaboration Project involves the FDA, the National Eye Institute and the U.S. Defense Department will examine quality of life issues after LASIK.

The first phase, which began in July 2009, involves a web-based questionnaire for patient responses to quality of life issues after LASIK. Phase 2 will study patients in a U.S. Navy refractive surgery centre. The final phase will be a clinical study of patients from the general population undergoing LASIK in various centres across the U.S.

I believe this is a welcome development as a thorough review of this surgical option for refractive error is long overdue.

LVC Complications

Laser vision correction (LVC) is a good alternative to spectacles or contact lenses for some patients, but in certain instances the outcome could be problematic. This is primarily due to the unpredictability of the corneal biomechanics and wound healing response. Despite the evolution of new technology, patients are still experiencing complications. Many patients are surprisingly quiet about such shortcomings, but we clearly need good data on how their lives are being impacted in the long term.

I am hoping that the FDA study will lead to improvements in how we advise prospective LVC patients as well as more effectively managing their postoperative experiences.

Clinicians can see the biological effects of LVC which the patient may not be aware of. Often the changes in the cornea are subtle but may be harbingers of future problems. Optometrists need to have more information to properly predict whether difficulties may arise when advising prospective patients considering LVC.

Most published studies of LVC outcomes are too narrow and do not fully reflect what clinicians are seeing. Some patients are able to maintain 6/6 vision with minimal refractive error for five years or more, but others are not so lucky. I have seen changes of up to several dioptres in spherical and cylindrical correction for best distance vision in some patients. There are the some horror stories on the internet and large law suits have occurred in the U.S., but I suspect the true incidence of patient dissatisfaction is not accurately known.

The Presbyopic Patient

Another big challenge is the presbyopic patient, who eventually has to wear spectacles for near vision. This means that there is a finite treatment window for the refractive error to stabilise, often when the patient is in their early thirties, until the onset of presbyopia, usually in the early to mid-forties.

Monovision, or so-called blended vision, only works in a sub-set of presbyopic patients. It should be mandatory for presbyopic patients to successfully trial monovision in contact lenses for a week or more before that modality can be properly implemented.

The key is to manage patients’ expectations. I encourage any patient who is considering LVC to do as much homework as they can, to scan the internet for information and to read about experiences others have had before going to a laser centre. That way, they are fully informed when they make their decision.

I remember the early hype when LVC first became a reality and thought it oversold its capability. When I was doing postdoctoral training in corneal physiology at the LSU Eye Center in New Orleans, the first clinical trials of PRK were underway. Some commentators at the time heralded this new procedure as replacing spectacles. This over-optimism has not been realised.

I am hoping that the FDA study will lead to improvements in how we advise prospective LVC patients as well as more effectively managing their postoperative experiences. The new results should offer greater insight into the factors that may influence LVC surgery and identify predictors for best outcomes.

An Eye Surgeon’s View

Cataract and Refractive Eye Surgeon Dr. Peter Sumich offered further background to the current study:

“A review of all global published studies on patient satisfaction through 2003 (pre-wavefront and Intralase) showed that 95.4 per cent were satisfied with their outcome. Plastic surgery procedures rated 70 to 90 per cent and cataract IOL rated 90 per cent.

“Commonest causes of dissatisfaction were residual refractive error in three per cent, significant dry eye one per cent and night vision symptoms in one per cent. Clearly, these three most common causes of dissatisfaction deserve to be shared with patients during informed consent.”

According to Dr Sumich, “the use of Intralase combined with the VISX CustomVue wavefront treatments (termed iLASIK) is quite likely to reduce even further the worst cases from patients who are dissatisfied. However, the satisfaction is already so high that it will be hard to beat across all entering refractions. My standard treatment is now to use ‘iLASIK’ on all suitable patients, in order to give them all the bells and whistles that technology can bring.

“That being said, there is no substitute for good patient selection and expectation management to maximise the likelihood of a happy outcome. Remember that mild depression and anxiety can occur in five to 10 per cent of the population at any given time, and there will always be people who will find dissatisfaction whether you are talking about a pair of spectacles, a new TV or Laser Vision Correction. If the ‘little birdie on my shoulder’ tells me not to go ahead with a particular patient, then I usually listen to it!”

Dr. Sumich believes “the current study will reinforce the current data that supports LASIK as a safe health intervention in appropriate patients. This is important to definitively establish, because LASIK has been performed on tens of millions of patients worldwide. I would expect that the results will be similar to the first study but with the worst cases reduced in their symptom severity.”


Dr. Stephen Kwok is an optometrist and corneal physiologist.