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Cover Focus: Corneal Refractive Surgery | Jul 2016

LASIK: Then and Now

The procedure is significantly safer and more effective today than when it was approved by the FDA.

First performed in Europe1-3 in 1989 and approved by the FDA in 1995,4 LASIK has grown to become the most successful elective procedure and the single most studied procedure in the world today.5 Although results of some of the earliest LASIK cases were suboptimal, with 6.8% of patients losing 2 or more lines of vision and only about 40% achieving 20/20 or better UCVA,6 today, visual results are more impressive. A recent review of the world literature found that between 2% and 6% of patients lose 2 or more lines of vision and that more than 90% achieve 20/20 or better UCVA.5

Addressing a room full of renowned surgeons at the American-European Congress of Ophthalmic Surgery (AECOS) winter symposium in Aspen, Colorado, Kerry D. Solomon, MD, said, “You begin to wonder why is it that, even today, 20 to 25 years after LASIK was developed, people still refer to the [old] numbers.”

Dr. Solomon is the first author of the aforementioned worldwide literature review on LASIK. “I am willing to bet … that most of our colleagues around the country, if not the world, still perceive LASIK [outcomes] as 50% [of patients] within 20/20,” he said.

The reality is that, today, after more than 10 million LASIK surgeries have been performed worldwide, the procedure is better than ever. “We continue to make [LASIK] better, but our peers do not notice. It is the biggest kept secret around,” Dr. Solomon said during his lecture. “I don’t think people realize how successful the procedure is, how much better the technology is, how much better we have gotten at screening our patients, and how much better we have gotten at helping our patients achieve the outcomes that they are looking for.”

It was for these reasons, and in preparation for the FDA’s public hearing on LASIK in 2008, that Dr. Solomon and colleagues extensively reviewed the literature on LASIK, from the procedure’s inception to the time of the FDA hearing. The review showed that more than 95% of patients were satisfied with their visual results, regardless of whether the reviewed articles were published closer to the inception of LASIK or to the FDA public hearing.

The literature review included datasets from 97 peer-reviewed articles including 68,000 eyes. “Seventy-one articles had a positive impression of LASIK, and 26 articles had a neutral impression; none had a negative impression,” Dr. Solomon said, adding that industry’s influence on these studies was minimal. “[Authors of] 33 articles reported a financial interest, 57 articles were authored independently, and five articles had no affiliation mentioned. Of the articles with financial interests, six had nonindustry funding. When we looked at the statistical analysis comparing the positive to neutral studies by financial interest, we did not find any evidence of bias based on financial involvement.”

The literature review found that 90.8% of patients achieved UCVAs of 20/20 or better and that 99.5% achieved 20/40 or better. Furthermore, with regard to safety, almost 1.5% of patients gained 2 or more lines of BCVA, and only 0.9% of eyes treated with conventional LASIK lost 2 or more lines. When only advanced LASIK treatment profiles were analyzed separately, 0.6% of patients in those studies lost 2 or more lines. These statistics, Dr. Solomon said, compare favorably to the 500-eye, FDA-sponsored Patient-Reported Outcomes With LASIK (PROWL) studies.7,8

“[LASIK] is significantly safer and more effective than it was when it was first approved by the FDA,” Dr. Solomon said. “The improvements in LASIK technology, such as advanced ablations, have yielded significantly better outcomes.”

1. Pallikaris I, Papatzanaki M, Stathi EZ, et al. Laser in situ keratomileusis. Lasers Surg Med. 1990;10:463-468.

2. Buratto L, Ferrari M, Genisi C. Keratomileusis for myopia with the excimer laser (Buratto technique): short-term results. Refract Corneal Surg. 1993:9(2 suppl);130-133.

3. Buratto L, Ferrari M, Genisi C. Myopic keratomileusis with the excimer laser: 1-year follow-up. Refract Corneal Surg. 1993;9:12-19.

4. Looking back: the history of laser vision correction. http://www.lasik.com/articles/laser-vision-correction-history. Accessed June 8, 2016.

5. Solomon KD, Fernández de Castro LE, Sandoval HP, et al. LASIK world literature review. Ophthalmology. 2009;116(4):691-701.

6. Kremer FB, Pronesti G, Solat J, et al. Prospective LASIK trial for myopia and myopic astigmatism: 1-year results. Ann Ophthalmol. 2001;33(4):315-322.

7. FDA website. Patient-reported outcomes with LASIK (PROWL-1) results. http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/UCM421192.pdf. Accessed June 7, 2016.

8. FDA website. Patient-reported outcomes with LASIK (PROWL-2) results. http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/SurgeryandLifeSupport/LASIK/UCM421193.pdf. Accessed June 7, 2016.

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