Meeting NewsPerspective

Modern LASIK outcomes on par with PROWL results

CHICAGO — In a literature review of a large series of eyes looking at modern LASIK outcomes, no article gave a negative impression of LASIK, Kerry D. Solomon, MD, told colleagues at Refractive Surgery Subspecialty Day preceding the American Academy of Ophthalmology meeting.

“We can definitively say that modern LASIK surgery is significantly safer and more effective than [when] it was first approved by the FDA,” Solomon said. “Clearly our modern results have improved over time, as you would expect, with better screening processes and better technology that is available to us today.”

Kerry D. Solomon

Kerry D. Solomon

Solomon and colleagues reviewed modern LASIK outcomes reported in 97 articles, representing 67,893 eyes, published in peer-reviewed literature between 2008 and 2015. Outcome data were categorized by treatment type, including conventional, advanced treatment profile and others not specified, and compared with results of recent FDA PROWL studies, as well as FDA nominal effectiveness criteria.

Uncorrected visual acuity, postoperative refractive error and safety outcomes all compared favorably with the PROWL studies, Solomon said.

When nominal FDA effectiveness criterion of 85% of patients achieving 20/40 or better UCVA is considered, “Across the board, whether it’s conventional, advanced treatment ablation or others, they all blew it out of the water. They are way, way better than what the FDA criteria is recommending,” Solomon said. Solomon reported UCVA of 20/20 or better of 90.8% in a series of 61,331 eyes and UCVA of 20/40 or better of 99.5% in a series of 59,833 eyes.

Regarding postoperative refractive error, 90.9% of nearly 60,000 eyes were within 0.5 D of the intended target refraction, and 98.6% of eyes were within 1 D of the intended target. These results are “way above” the nominal FDA effectiveness standard of 75% within 1 D, Solomon said, and “again, compares favorably with what the PROWL results showed.”

The FDA PROWL study outcomes are consistent with those reported in the literature and demonstrate high patient satisfaction and excellent safety and outcomes, Solomon said.

“By every metric we looked at, our LASIK results are better than they were 10 to 15 years ago,” Solomon said. – by Patricia Nale, ELS

Reference:

Solomon KD. Modern LASIK outcomes: A review. Presented at: American Academy of Ophthalmology annual meeting; Oct. 14-18, 2016; Chicago.

Disclosure: Solomon reports financial relationships with Alcon, Allergan, Abbott, Bausch + Lomb, ClarVista, Glaukos, Icon Pharmaceuticals, Imprimis, Integrity Digital Solutions, Lenstec, Kala, Mati Therapeutics, OcuHub, Octane Visionary VC, Omeros, PogoTec, PRN Nutraceuticals, Versant Ventures and Zeiss.

CHICAGO — In a literature review of a large series of eyes looking at modern LASIK outcomes, no article gave a negative impression of LASIK, Kerry D. Solomon, MD, told colleagues at Refractive Surgery Subspecialty Day preceding the American Academy of Ophthalmology meeting.

“We can definitively say that modern LASIK surgery is significantly safer and more effective than [when] it was first approved by the FDA,” Solomon said. “Clearly our modern results have improved over time, as you would expect, with better screening processes and better technology that is available to us today.”

Kerry D. Solomon

Kerry D. Solomon

Solomon and colleagues reviewed modern LASIK outcomes reported in 97 articles, representing 67,893 eyes, published in peer-reviewed literature between 2008 and 2015. Outcome data were categorized by treatment type, including conventional, advanced treatment profile and others not specified, and compared with results of recent FDA PROWL studies, as well as FDA nominal effectiveness criteria.

Uncorrected visual acuity, postoperative refractive error and safety outcomes all compared favorably with the PROWL studies, Solomon said.

When nominal FDA effectiveness criterion of 85% of patients achieving 20/40 or better UCVA is considered, “Across the board, whether it’s conventional, advanced treatment ablation or others, they all blew it out of the water. They are way, way better than what the FDA criteria is recommending,” Solomon said. Solomon reported UCVA of 20/20 or better of 90.8% in a series of 61,331 eyes and UCVA of 20/40 or better of 99.5% in a series of 59,833 eyes.

Regarding postoperative refractive error, 90.9% of nearly 60,000 eyes were within 0.5 D of the intended target refraction, and 98.6% of eyes were within 1 D of the intended target. These results are “way above” the nominal FDA effectiveness standard of 75% within 1 D, Solomon said, and “again, compares favorably with what the PROWL results showed.”

The FDA PROWL study outcomes are consistent with those reported in the literature and demonstrate high patient satisfaction and excellent safety and outcomes, Solomon said.

“By every metric we looked at, our LASIK results are better than they were 10 to 15 years ago,” Solomon said. – by Patricia Nale, ELS

Reference:

Solomon KD. Modern LASIK outcomes: A review. Presented at: American Academy of Ophthalmology annual meeting; Oct. 14-18, 2016; Chicago.

Disclosure: Solomon reports financial relationships with Alcon, Allergan, Abbott, Bausch + Lomb, ClarVista, Glaukos, Icon Pharmaceuticals, Imprimis, Integrity Digital Solutions, Lenstec, Kala, Mati Therapeutics, OcuHub, Octane Visionary VC, Omeros, PogoTec, PRN Nutraceuticals, Versant Ventures and Zeiss.

    Perspective
    Marianne Price

    Marianne Price

    Many patients have misconceptions about LASIK based on outdated information from early lasers and treatment profiles and are unaware of the excellent vision and high satisfaction rates consistently documented in all recent studies of LASIK worldwide. Dr. Solomon’s literature review confirms that LASIK is safe and highly effective at correcting refractive error. These findings reinforce the excellent results seen in the FDA-sponsored PROWL studies. What patients may be most surprised to learn is that visual symptoms are very common with other forms of vision correction, such as glasses or contact lenses. These studies show that LASIK actually reduces the prevalence of visual symptoms, such as difficulty with driving at night. This is key information to share with patients as they make choices about vision correction options.

    • Marianne Price, PhD
    • Executive Director, Cornea Research Foundation of America

    Disclosures: Price reports financial relationships with Alcon, Calhoun Vision, Haag Streit, RevitalVision, TearLab and Transcend.

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