AcrySof Phakic Angle-supported Intraocular Lens for the Correction of Moderate-to-High Myopia: One-Year Results of a Multicenter European Study

Purpose To investigate the safety and effectiveness of the AcrySof phakic angle-supported intraocular lens (IOL) (Alcon Laboratories, Inc., Fort Worth, TX) for correction of moderate-to-high myopia in adults. Design One-year interim analysis of a phase 3, nonrandomized, open-label, prospective, multicenter European clinical study. Participants A total of 190 subjects (190 eyes) with moderate-to-high myopia. The preoperative mean manifest refraction spherical equivalent (MRSE) was −10.38 diopters (D) ±2.43 standard deviation (SD). Methods Unilateral implantation of the AcrySof phakic angle-supported IOL. Main Outcome Measures Best spectacle-corrected visual acuity (BSCVA), uncorrected distance visual acuity (UCVA), predictability and stability of MRSE, adverse events, and endothelial cell density. Results Of 190 subjects enrolled, 161 completed the 1-year postoperative visit. No subjects lost ≥2 lines BSCVA. A UCVA of 20/20 or better was achieved by 57.8%; 99.4% had 20/40 or better. A BSCVA of 20/32 or better was achieved by 100% of subjects; 85.7% had 20/20 or better. The mean MRSE was −0.23 D (±0.50 D: −2.50 to 0.75 D). Residual refractive error was within ±1.0 D from the target for 95.7% of subjects and within ±0.5 D for 72.7% of subjects. The overall mean percentage change in central endothelial cell density 1 year after surgery was −4.77±8.04% (n = 139). No pupil ovalization, pupillary block, or retinal detachment events were observed. Conclusions The AcrySof phakic angle-supported IOL yielded excellent refractive correction and predictability with acceptable safety in subjects with moderate-to-high myopia. These 1-year interim analysis findings demonstrate preliminary support for the safety and efficacy of this IOL. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.