FDA releases new patient-reported outcome measure to better assess LASIK patients

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LASIK (Laser-Assisted in Situ Keratomileusis) eye surgery is performed on between 600 and 800 thousand patients every year in the US and is a growing alternative for those who need glasses or contact lenses for their vision.

While the surgery is generally very successful, some patients develop unwanted visual symptoms following surgery that can have a significant impact on their lives including: starbursts, glare, ghosting, halos and severe dry eyes.

The FDA has long been interested in assessing these adverse potential side-effects of LASIK eye surgery and along with the NIH, the Department of Defense and a study called PROWL, have developed a new patient-reported outcome measure to assess LASIK patients before and after surgery.

A recent study published in JAMA Ophthalmology by Dr. Malvina Eydelman MD of the FDA, et al. examined the results of the PROWL-1 and PROWL-2 studies that used this new patient-reported outcome measure.

They found that although 95% of patients were satisfied with their vision after surgery, 43% experienced new visual symptoms.

“Given the excellent visual acuity outcomes with corneal refractive surgery, the next step for refractive surgeons should be to maximize patient satisfaction and quality of life by minimizing the onset of visual and dry eye symptoms, and potentially decreasing the frequency of these symptoms if they are present preoperatively,” stated Alan Sugar, MD, University of Michigan Medical School, and colleagues in a clinical review of the PROWL studies.

They further commented on the potential of this new patient-reported outcome measure as a tool that can be used in practice:

“The PROWL instrument is a starting point to allow ophthalmologists to better measure outcomes in this regard. Larger and longer-term studies are needed to determine the predictors of the new onset of visual symptoms, which would enhance preoperative patient counseling, and identify novel ways to reduce the risk of symptoms.”

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