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 > or =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.
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 > or =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.
Authors: Soraya M R Jonker; Tos T J M Berendschot; Isabelle E Y Saelens; Noël J C Bauer; Rudy M M A Nuijts Journal: Indian J Ophthalmol Date: 2020-12 Impact factor: 1.848