Abstract
PURPOSE: To evaluate the 6-month effectiveness and safety of a new foldable multifocal iris-fixated phakic intraocular lens (pIOL) for presbyopia correction. SETTING: Multicenter study at 7 sites. DESIGN: Nonrandomized prospective clinical trial. METHODS: Presbyopic patients without cataracts undergoing bilateral multifocal pIOL implantation (Ophtec ArtiPlus) were studied. The primary outcome for efficacy was the visual acuity at distance, intermediate, and near. Secondary outcomes included endothelial cell density (ECD), postoperative refraction, binocular defocus curve, vision quality, spectacle independence, and patient satisfaction. RESULTS: 49 subjects (98 eyes) were included. At 6 months, the mean binocular uncorrected distance intermediate, and near visual acuity was -0.05 ± 0.09 logMAR, -0.02 ± 0.07 logMAR, and 0.02 ± 0.08 logMAR, respectively. The ECD remained stable with a mean value of 2771 ± 289 cells/mm 2 at 6 months postoperatively. The mean spherical equivalent was -0.42 ± 0.33 diopters (D), with 95% eyes having a prediction error within ±1.0 D and 77% within ±0.5 D. The binocular distance-corrected defocus curve showed a visual acuity of 0.20 logMAR or better over a range of +1.0 to -3.5 D. Patient satisfaction was high, with a mean score of 3.5 on a 4-point scale, and 83% of the patients reported spectacle independence. 47%, 35%, and 96% of patients reported experiencing glare, halos, and starbursts at well-tolerated levels, respectively. Notably, only 2% of patients found halos and starbursts to be very bothersome. CONCLUSIONS: Bilateral ArtiPlus multifocal pIOL implantation demonstrated good visual acuity from distant to near and maintained stable ECD over 6 months. Patients reported high levels of satisfaction and spectacle independence, despite some optical disturbances.