Lisbon, Portugal—The AcrySof angle-supported phakic IOL (Alcon Laboratories) seems to be safe and effective based on the preliminary clinical outcomes of the U.S. clinical trial that were reported at the European Society of Cataract and Refractive Surgeons annual meeting. The IOL provides significant improvements in correcting stable, high myopia, according to Ronald Krueger, MD.
The IOL has a 6-mm optic and a range of dioptric powers from –6 to –16.5 D.All patients in the assessment trial of this lens were 18 to 49 years old, with good ocular health and a stable refraction that was defined as remaining within 0.5 D of change within the previous year.
Subjects were excluded from participation if they had an anterior chamber depth less than 3.2 mm, astigmatism greater than 2 D, mesopic pupil diameter greater than 7 mm, or endothelial cell density not meeting protocol criteria per age. All patients received unilateral implants of the IOL using the Monarch II Injector (Alcon).
The predictability of the IOL was excellent, with 100% of eyes within ±1.0 D (the FDA requirement for this is 75%). Eighty-five percent of the eyes were within ±0.5 D of the target refraction (FDA requirement is 50% of eyes).
No eyes lost more than 2 lines of BCVA, 30% of subjects gained 1 line of BCVA, and in 60% there was no change. One eye developed a cataract, and in one eye the IOL was explanted because of incorrect lens power.
"The IOL is rated highly for uncorrected visual acuity, predictability, and safety. Continued follow-up is needed to determine the safety and effectiveness over the long term," Dr. Krueger stated.