Clinical performance supports role of phakic lens

March 15, 2005

New Orleans—Results from continued follow-up of myopic eyes enrolled in the FDA clinical trial of the Verisyse phakic lens (Advanced Medical Optics) support the conclusion that the iris-fixated implant is a safe, effective, and very useful adjunct in a refractive surgery practice, said Richard L. Lindstrom, MD, at a session during the International Society of Refractive Surgery of the American Academy of Ophthalmology annual meeting.

"We continue to be very pleased with the refractive and visual outcomes and have found complications to be minimal and manageable," commented Dr. Lindstrom, adjunct professor emeritus, department of ophthalmology, University of Minnesota, and founder, Minnesota Eye Consultants, Minneapolis.

He presented results from the first 157 eyes of 83 patients undergoing implantation. The preoperative myopic treatment range was between -5 and -20 D (mean -12 D), and the patients ranged in age from 21 to 53 years (mean 40 years). One hundred forty-one eyes were seen at 1 year, and 71 eyes had reached the 3-year follow-up visit.

Best-corrected visual acuity was 20/40 or better in 99.3% of eyes at 1 year and in all eyes evaluated after 3 years.

The predictability analyses showed that at both 1 and 3 years, about 70% of eyes were corrected to within 0.5 D of target refraction.

"These results are consistent with the predictability that can be achieved with any type of lens implant given dependence on the vertex distance of the lens implant," Dr. Lindstrom said. "However, the participants within the clinical trial were also allowed to have up to 2.5 D of astigmatism, which could only be treated by moving the incision to the steeper meridian."

That technique, use of corneal relaxing incisions, or excimer laser enhancement after the eye has healed from the phakic IOL surgery are now options for managing significant astigmatism or fine-tuning spherical power in patients undergoing implantation of the Verisyse lens since it became commercially available. Secondary surgery with relaxing incisions or laser enhancement are also being offered to correct residual astigmatism in patients who were participants in the FDA trial.

"Interestingly, we are finding that most of our patients with high myopia with spherical errors of about -12 D or greater are usually pretty satisfied with their outcomes despite having some mild residual ametropia, and so our enhancement rate is lower than we anticipated," he said.