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After 4 years of follow-up in a clinical trial, the angle-supported foldable acrylic phakic IOL is continuing to provide patients treated for moderate to high myopia with good visual acuity thanks to accurate predictability, a stable refractive outcome, and good safety.
"The safety outcomes for angle-supported phakic IOLs have been tarnished by experiences from Europe where very different IOL designs and materials were used, leading to the removal of most phakic anterior chamber IOLs from the European market," said Dr. Lane, medical director, Associated Eye Care, St. Paul, MN, and adjunct clinical professor of ophthalmology, University of Minnesota, Minneapolis. "In contrast, safety measures with the Cachet phakic IOL show excellent maintenance of best-corrected visual acuity (BCVA) and minimal changes over time in endothelial cell density.
"Importantly, there have been no eyes with pupil ovalization >1 mm, BCVA loss >0.2 logMAR, retinal detachment, retinal repair, iritis, IOP elevation requiring treatment, corneal stromal edema, lens dislocation, or corneal haze," he added.
The AcrySof Cachet IOL is CE marked in Europe for the correction of moderate to high myopia, but still is investigational in the United States. The lens has a single-piece design with a 6-mm optic and overall lengths varying from 12.5 to 14 mm across the available dioptric range (–6 to –16.5 D).
The phase II study included 50 patients and analyzed data from the first eye implants. Eligible patients ranged in age from 18 to 49 years and had to demonstrate stable moderate to high myopia and be in good ocular health. Mean preoperative MRSE was –10.04 ± 2.27 D.
Eyes were excluded if the anterior chamber depth was ≤3.2 mm, astigmatism was ≥2 D, or mesopic pupil size was >7 mm. Exclusions based on endothelial cell density were age-based and determined using a grid established with the FDA. Astigmatic correction was not allowed.
These criteria were carried into the phase III study, Dr. Lane said.