Which LASIK Laser Is Best?

Excimer lasers, manufactured to perform laser-assisted in situ keratomileusis (LASIK), are, one and all, marvels of modern medicine. Many potential LASIK recipients, though, are interested in the subtle differences among the currently approved instruments.

But for most people, the choice of laser makes no significant difference. Most experts agree that surgeon skill and experience and the quality of care before and after LASIK are far more critical factors affecting final vision outcomes.

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Although all approved lasers meet safety and effectiveness criteria established by the U.S. Food and Drug Administration (FDA), certain patients may be better off with one type of laser over another.

When comparing lasers, the informed consumer naturally is drawn to the data gathered during FDA clinical trials. A number of important points can help keep the FDA data in perspective:

1. Today's results are probably better than FDA data. By definition, FDA trials occur during the early period of a laser's life cycle. Manufacturers are allowed to and often do make technical improvements to the instruments, sometimes even while the lasers are still under investigation. This, together with increasing surgeon experience over time, means that results in actual clinical practice are often better than the initial FDA data.
    
2. FDA data in one study cannot fairly be compared with FDA data in another study. Manufacturers go to the FDA with various study designs, which often have differing endpoints and patient-enrollment criteria. Although all studies must answer certain basic questions regarding safety and effectiveness, they are not designed to be compared with one another. A true comparison of Laser A and Laser B would require randomized clinical trials (RCTs), in which patients would be randomly assigned to receive surgery by one laser or the other over the same time period by the same surgeons. FDA trials don't do that, although other studies sometimes do.
    
3. Studies don't cover every possibility. Just because you have a characteristic or condition that is not covered by the approved labeling of a laser doesn't mean that the laser won't work for people with your characteristic or condition. Neither does it mean that another laser approved to treat people with your characteristic will do a better job. Remember, these studies have differing designs, and people with your characteristic or condition may or may not have been included, or their results may or may not have been analyzed, or there may have been too few such people in the studies to determine statistical or clinical significance.
    
4. Once the FDA approves a laser, your surgeon can use it any way he or she deems appropriate. This is true of all FDA-approved drugs and devices. This is commonly referred to as "off-label" use of an FDA-approved drug, device, or laser. It's called a physician's practice-of-medicine prerogative, and there's nothing inherently wrong with it. In medicine, doctors often use one technology for a patient with a condition that was not in the FDA clinical trial. The use of that equipment in this regard is called "off-label," while characteristics included in the FDA study are "on-label." A common example of off-label use is a doctor recommending aspirin to reduce the risk of stroke, although aspirin originally was FDA approved for pain relief.
    

Armed with this insight, the informed consumer can begin to compare the commercially available laser systems approved for LASIK (see chart on page 2 of this article). Most discussion of these lasers surrounds the mechanisms they employ to deliver the laser beam and track the eye during ablation.

Page 2: Compare LASIK lasers on a handy chart and read more about the importance of pupil size.