Eyeworld

45 EW REFRACTIVE August 2016 A recent review looking at literature pertaining to LASIK outcomes will be published in the August issue of JCRS A n upcoming article in the August issue of the Journal of Cataract & Refractive Surgery (JCRS) titled "Modern LASIK out- comes, a review" will look at LASIK outcomes by detailing an extensive literature review. Researchers sought to examine clinical outcomes in peer-reviewed literature. Overall, the literature suggests that LASIK for the correction of refractive error contin- ues to improve in both safety and efficacy. The study included articles from 2008 to 2015 and ultimately identified 97 articles, which includ- ed 67,893 eyes. "We had done a previous lit- erature review to look at the issue specifically in terms of patient satisfaction," said Kerry Solomon, MD, Mt. Pleasant, South Carolina. It was conducted at a time when the FDA was very interested in patient satisfaction, he added. This initial review looked at literature from the inception of LASIK until about 2008, focusing on satisfaction. It was expressly done in response to complaints of early complications with LASIK. The FDA then under- took a project subsequent to that to develop a questionnaire and began to look at patient-reported outcomes with LASIK, Dr. Solomon said. This was the recent PROWL study, he said, and preliminary findings demonstrated good outcomes from the parameters that were evaluated. The purpose of this most recent literature review, Dr. Solomon said, was to see if the literature would be consistent with what the PROWL study showed. "Since the PROWL study was only a 3-month study, it did have some limitations, but we wanted to see if its basic pretense could be held up with literature reviews." This involved examining whether modern LASIK is safe and effective, if patients are getting the results they desire, and if the results have improved over time. Thousands of articles were reviewed and the relevant ones were those that specifically looked at and reported on outcomes, Dr. Solomon said. From there, 97 articles were identified. Two different validated grading systems were used to iden- tify these articles based on scientific strength and commercial bias. There was no difference found in the out- comes reported and no industry or reported bias. In all, more than 60,000 eyes were reported on. "We think that the literature review was very strong," Dr. Solomon said. "LASIK is safe and effective. Outcomes are better than they've ever been and certainly better than when it was first approved." Although some side effects—such as glare, dry eye, and trouble with night vision—remain, there are fewer incidences of these side effects than when LASIK was first approved. Helga Sandoval, MD, Mt. Pleasant, South Carolina, the lead author, did the majority of the work, Dr. Solomon said, and she had some assistance from physicians and re- searchers as well. These articles and data were collected over a period of 6 months to a year. In the review, there was no apparent industry bias, and none of the articles left a "negative" impres- sion on the reader. Furthermore, the patient satisfaction rate in all of the studies reporting on satisfaction was 98.7%. In terms of BCVA, there was generally no change shown, and twice as many eyes gained 2 or more lines of vision than lost 2 or more lines. The loss of 2 or more lines of BCVA was 0.61% (359/58,653). The spherical equivalent refrac- tion was within 1.0 D of intended in 98.6% (59,476/60,329) of eyes, with 90.9% (59,954/65,974) within 0.5 D (of the groups where this data was reported). "I think we still have some edu- cation to do with our ophthalmolo- gy and eyecare provider communi- ty," Dr. Solomon said. When LASIK was first approved, 20/20 rates were around 60%, and today they are 90% or more, he said. The 20/25 rate is 98–99%. Most people are close to their intended refraction following LASIK, patient satisfaction is high, and quality of vision is excellent, Dr. Solomon said. "The biggest point for me was that the data was as good as it was, and it was consistently good across multiple articles," he said. EW Reference 1. Sandoval HP, et al. Modern LASIK outcomes, a review. J Cataract Refract Surg. 2016;42. Article in press. Editors' note: Dr. Solomon has no financial interests related to his com- ments and played no role in the collec- tion or analysis of data or screening of articles. Contact information Solomon: Kerry.Solomon@carolinaeyecare.com by Ellen Stodola EyeWorld Senior Staff Writer Literature review examines LASIK outcomes " We think that the literature review was very strong. LASIK is safe and effective. Outcomes are better than they've ever been and certainly better than when it was first approved. " –Kerry Solomon, MD

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