PURPOSE: To evaluate the safety and effectiveness of an angle-supported phakic intraocular lens (pIOL) for correction of moderate to high myopia. SETTING: Ophthalmology centers in the United States, Canada, and the European Union. DESIGN: Cohort study. METHODS: This study comprised patients with moderate to high myopia (range -6.00 to -16.50 diopters [D]) who had implantation of the AcrySof Cachet pIOL. Outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), predictability, stability of the manifest refraction spherical equivalent (MRSE), adverse events, and endothelial cell density (ECD). RESULTS: Pooled interim data from 360 patients assessed for up to 3 years postoperatively are presented. Of the 104 patients who reached the 3-year visit, the UDVA was 20/40 or better in 101 (97.1%) and 20/20 or better in 48 (46.2%). The CDVA was 20/32 or better in 103 (99.0%) of the 104 patients and 20/20 or better in 84 patients (80.8%). The mean MRSE was -0.24 D ± 0.55 (SD) (range -2.00 to 1.63 D). The residual refractive error was within ±0.50 D of target in 82 patients (78.8%) and within ±1.00 D in 95 patients (91.3%). The annualized percentage loss in central ECD and peripheral ECD from 6 months to 3 years was 0.41% and 1.11%, respectively. No pupil ovalization, pupillary block, or retinal detachment was observed. CONCLUSIONS: Three-year findings from pooled global studies showed that the angle-supported pIOL provided favorable refractive correction and predictability and acceptable safety in patients with moderate to high myopia.
RCT Entities:
PURPOSE: To evaluate the safety and effectiveness of an angle-supported phakic intraocular lens (pIOL) for correction of moderate to high myopia. SETTING: Ophthalmology centers in the United States, Canada, and the European Union. DESIGN: Cohort study. METHODS: This study comprised patients with moderate to high myopia (range -6.00 to -16.50 diopters [D]) who had implantation of the AcrySof Cachet pIOL. Outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), predictability, stability of the manifest refraction spherical equivalent (MRSE), adverse events, and endothelial cell density (ECD). RESULTS: Pooled interim data from 360 patients assessed for up to 3 years postoperatively are presented. Of the 104 patients who reached the 3-year visit, the UDVA was 20/40 or better in 101 (97.1%) and 20/20 or better in 48 (46.2%). The CDVA was 20/32 or better in 103 (99.0%) of the 104 patients and 20/20 or better in 84 patients (80.8%). The mean MRSE was -0.24 D ± 0.55 (SD) (range -2.00 to 1.63 D). The residual refractive error was within ±0.50 D of target in 82 patients (78.8%) and within ±1.00 D in 95 patients (91.3%). The annualized percentage loss in central ECD and peripheral ECD from 6 months to 3 years was 0.41% and 1.11%, respectively. No pupil ovalization, pupillary block, or retinal detachment was observed. CONCLUSIONS: Three-year findings from pooled global studies showed that the angle-supported pIOL provided favorable refractive correction and predictability and acceptable safety in patients with moderate to high myopia.
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