Purpose: To investigate in a pilot study the potential of an anterior chamber phakic refractive multifocal intraocular lens (IOL) prototype for the correction of near and far vision in those with myopic and hyperopic presbyopia.
Design: A multicenter, open-label, prospective, noncomparative pilot evaluation.
Participants: There were 17 patients (34 eyes), 16 women and 1 man, with a mean age of 52+/-3.94 years (range, 46-62 years). Six eyes were myopic (mean spherical equivalent [SE], -9.3+/-3.83 diopters (D)) and 28 were hyperopic (mean SE, +2.3+/-0.77 D), with astigmatism less than 1.5 D.
Methods: The prototype multifocal phakic IOL was implanted through a 6.5-mm temporal incision. The dominant eye was targeted for emmetropia and the nondominant eye for -1.0 D.
Main outcome measures: The efficacy of the implant was assessed after surgery by measuring monocular and binocular uncorrected and distance-corrected visual acuity (VA) at distance, intermediate, and near, and distance-corrected near VA with near add. Distance-corrected distance and near VA also were determined in low contrast (25%). The safety index and efficacy index were calculated, and patient satisfaction questionnaires also were administered. Follow-up was at 1-3 days, 5-9 days, 21 days, 3 months, 6 months, and 1 year after surgery.
Results: Spherical equivalent refraction ranged from -11.75 to +4.25 D before surgery, and from -2.0 to +1.85 D 1 year after surgery. The binocular efficacy index was 0.68 (near) and 1.0 (distance), and the binocular safety index was 1.0 for both near and distance. Mean binocular uncorrected distance VA improved from 20/59 (+/-4 lines) before surgery to 20/18 (+/-1 line) 1 year after surgery. Mean binocular uncorrected intermediate VA improved from 20/125 (+/-10 lines) to 20/21 (+/-1 line), and mean binocular uncorrected near VA improved from 20/78 (+/-5 lines) to 20/32 (+/-1 line). Binocular uncorrected visual acuity was at least 20/40 (distance and intermediate) and Jaeger 3 in 88.2% of patients, and it was at least 20/40 and Jaeger 5 in 100% of patients. Patient satisfaction was very good in 88% of patients (15 of 17); the remaining 2 patients reported moderate satisfaction.
Conclusions: Promising results were obtained with the refractive multifocal phakic IOL prototype investigated in this pilot study for near and far visual correction in presbyopia associated with myopia and hyperopia. Multifocal phakic intraocular optics may be an option for presbyopia correction.