Looking back-and ahead-at LASIK’s potential

Take-home message: LASIK has continued to improve over time and will see further refinements thanks to better preop testing and technological advances.

Reviewed by Eric D. Donnenfeld, MD

Interest in LASIK has declined for several years-is the procedure worth saving?

The answer is an unequivocal “yes,” according to Eric D. Donnenfeld, MD.

The procedure has undergone numerous refinements in efficacy, safety, and patient selection, so it still is a viable option for many patients, said Dr. Donnenfeld, founding partner of Ophthalmic Consultants of Long Island and Connecticut, Rockville Centre, NY, and clinical professor of ophthalmology, New York University Medical Center, New York..

Dr. Donnenfeld reviewed the clinical history of LASIK and discussed myths and misconceptions associated with the procedure.

The “red-letter day” for LASIK in the United States was Oct. 20, 1995, when the Summit excimer laser was first improved in the FDA, he noted. At that time, one FDA trial showed that 80% of patients achieved 20/20 uncorrected visual acuity (UCVA), and 98% had 20/40 or better UCVA. Several patients-6.8%-lost two more lines of best-corrected visual acuity.

Despite the initial LASIK fanfare, some complications were associated with it, and that is likely what led to the establishment of LASIK complications websites and foundations that continue today, Dr. Donnenfeld said.

“Their goals are noble and should be embraced,” he said. “Yet, it’s unfortunate that the activists and ophthalmologists have not gotten together to work constructively to improve outcomes.”

Some complications

Some complications revealed earlier on via the peer-review literature included flap-related problems, ectasia, dry eye, and infections. One common infectious issue, atypical mycobacteria, has nearly been eliminated because of antibiotics and the realization that tap water is a contaminant, Dr. Donnenfeld said.

Studies related to dry eye and LASIK have found that although there is a significant loss of corneal sensation with LASIK, it improves after 3 to 6 months.

An FDA hearing took place in 2008 to review LASIK concerns, said Dr. Donnenfeld, who both spoke on behalf of LASIK at the hearing and listened to many of the patients giving testimonies with stories about depression, suicide, and other mental issues tied to previous LASIK.

“Overwhelmingly, the most common concern I heard patients felt is abandonment by their surgeon,” he said. “I promised myself that would never happen at my practice.”

After the hearing, the only action the FDA took was updating some of the LASIK-related information on its website, Dr. Donnenfeld said.

More recently, results released last year from the FDA’s PROWL 1 and 2 studies showed that 99% and 96% of subjects achieved 20/20 bilateral UCVA, with no enhancements needed.

The study also demonstrated LASIK’s safety. Dr. Donnenfeld was surprised to learn from the research that most subjects with glare and halo before LASIK actually had a reduction in these symptoms after LASIK. He had always presumed that these patients were not good candidates for the procedure.

Although the FDA studies did show that 30% of patients got new dry eye after LASIK, that was evaluated at 3 months; Dr. Donnenfeld believes the results would have been lower had they waited until 6 months.

Research that focuses on patient satisfaction has found that LASIK has the highest patient satisfaction rate of any procedure done on an elective basis today, with 91% to 100% of patients satisfied in various studies, Dr. Donnenfeld reported.¹

Researchers also have busted the myth that ophthalmologists do not get LASIK done on their own eyes-they are actually four times more likely to have laser vision correction compared with the general population.²

Looking Forward

Looking forward

Recent technological improvements have strengthened LASIK’s potential, including pupil tracking, haze management, customized and optimized ablations, and better diagnostic equipment, Dr. Donnenfeld said.

However, there are further refinements that will take place.

“We have an unmet need with dry eye, but we now know that preoperative testing to elucidate dry eye before surgery can make a difference,” he said. “We have thinner and smaller flaps, topical cyclosporine, and a slew of new medications for dry eye that will be coming soon.”

Additionally, new advanced wavefront technology and topographic lasers will expand the potential to treat irregular corneas via LASIK, he said.

References

1. Solomon KD, Fernandez de Castro LE, Sandoval HP, et al. LASIK world literature review. Ophthalmology. 2009;116:691-701.

2. Pasquali TA, Smajda D, Savetsky MJ, et al. Long-term follow-up after laser vision correction in physicians: Quality of life and patient satisfaction. J Cataract Refract Surg. 2014;40:395-402.

Eric D. Donnenfeld, MD

E: [email protected]

This article was adapted from Dr. Donnenfeld’s presentation at the 2015 meeting of the American Academy of Ophthalmology. Dr. Donnenfeld did not indicate any proprietary interest in the subject matter.