Med Device Monday: LASIK Study

LASIK is a well-known surgery that's not quite new. Designed to correct eyesight and eliminate or reduce the need for daily contact lenses or glasses, it was approved by FDA in 1999. LASIK (Laser-Assister In Situ Keratomileusis) works by permanently changing the shape of the cornea in order to alter vision. It is of course meant to be a positive, life-changing medical procedure, but as with any procedure or medical device, it is not without risk. 

This video is a bit dry, but it outlines the procedure, its intended outcome, and the associated risks:

In 2009, ten years after LASIK was granted by FDA, the National Eye Institute (NEI) and the Department of Defense (DoD) began working together on something called the LASIK Quality of Life Collaboration Project (LQOLCP). This joint effort was designed to get a solid look at patient outcomes by speaking directly with patients both before and after their procedures. In other words, the study sought to determine not just a level of satisfaction, but a relative level of satisfaction. And of course, this helps inform labelling and patient expectations when considering the surgery. The program itself sums it up:

"The project aimed to develop a tool to determine the percent of patients who develop difficulties performing their usual activities following LASIK, and to identify predictors for those patients.

At the time we developed our project, there was a limited amount of valid scientific data on certain patient-reported outcomes (PROs) related to LASIK. A PRO is a report of a condition experienced and reported by the patient, not the health care provider.

Most LASIK studies used tools, such as questionnaires, to assess visual symptoms, but only after the surgery. The Patient-Reported Outcomes with LASIK (PROWL) studies in the LQOLCP assessed visual symptoms both before and after their LASIK surgery to identify changes over time. The studies also measured the impact symptoms directly had on performing usual activities, which had not previously been done."

Various steps were taken in this study, which you can read about in detail in the link above. The study began in 2011 with patients who were contemplating LASIK surgery. Patients were interviewed and asked to complete carefully researched and conducted surveys designed to gauge their pre-surgery feelings and experience. In 2014, the second half of the study began: one part was conducted in the civilian population, and the other right here in San Diego at the Balboa Naval Hospital. The study helped establish new measurements of success and side effects for the procedure: "...new scales that can be used to more thoroughly assess candidates' symptoms before LASIK surgery, monitor them for visual symptoms as well as satisfaction after LASIK surgery, and measure the impact any post-LASIK symptoms have on a patient's ability to function." What the studies found is that LASIK is generally quite successful in terms of both results and patient satisfaction. Check out the details below:

Screenshot from FDA.gov.

Screenshot from FDA.gov.

While careful planning and testing of devices is essential to get FDA approval and get your device to market, it's certainly satisfying to see a follow-up study showing that the procedure is still successful–particularly after it's been on the market for some time. It also makes sense to continue to evaluate the effectiveness and impact of a device in order to help inform patients who may consider it! 

For further reading on this topic:

FDA's LASIK information center

FDA-approved Lasers for PRK and Other Refractive Surgeries

FDA's role in LASIK