At 5 years, clinical results of phakic IOL continue to be encouraging

ROME — Clinical results of the Alcon AcrySof phakic IOL continue to be reassuring at 5 years after implantation, a surgeon said here. Visual performance is good, and no long-term surprises concerning endothelial cell loss or other complications have been noted.

In a prospective, multicenter, European clinical trial — the largest study on the phakic AcrySof — 190 patients have so far undergone unilateral implantation with this lens. The 5-year follow-up visit was completed by 77 subjects and included evaluation of uncorrected and best corrected visual acuity, stability of postoperative refraction, chronic endothelial cell density changes from 6 months to 5 years, and adverse events.

"Mean postoperative [manifest refraction spherical equivalent] remained stable at 5 years (–0.25 ± 0.54 D) and was within ±0.5 D of target in 77.9% of subjects. UCVA of 20/25 or better was achieved by 71.4% of subjects. All subjects achieved BCVA of 20/40 or better, 97.4% achieved 20/25 or better, and 80% were 20/20 or better," Jorge L. Alió, MD, PhD, said at the winter meeting of the European Society of Cataract and Refractive Surgeons.

Positive data continue to be reported on the annualized percent change in endothelial cell density, which was –1.07% centrally and –1.79% peripherally at 5 years from 6 months postop.

"Thanks to these results, the AcrySof has resuscitated the concept of angle-supported phakic IOLs, which seemed at some point a lost cause. As far as [endothelial cell density] is concerned, this lens is extremely respectful and stable, with no significant changes shown at 5 years," Dr. Alió said.

Cumulative serious adverse events rates for the study were low and included cataract (3.2%, related to surgery or age), increased IOP requiring treatment (3.2%), synechiae (1.6%) and BCVA loss of more than two lines (0.5%). No pupil ovalization was reported with any of the lenses.