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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. [Copyright &y& Elsevier]

Purpose: To evaluate safety and efficacy of an intracorneal inlay for the correction of hyperopia. Design: A prospective, nonrandomized, noncomparative, 2-center study. Participants: Thirty-four hyperopic eyes were implanted with a hydrogel intracorneal inlay (Permavision, Anamed, Lake Forest, CA). Preoperative hyperopia was +3.9 diopter (D; range, +2 to +7). Uncorrected visual acuity (UCVA) was the logarithm of the minimum angle of resolution (logMAR; the decimal logarithm of decimal visual acuity with a minus sign) 0.6 ± logMAR 1, and best-corrected visual acuity (BCVA) was logMAR 0.1 ± 0.7. Methods: Corneal flaps were created with a mechanical microkeratome (M2 [Moria, Anthony, France] or Amadeus [Advanced Medical Optics Inc, Santa Ana, CA]; 180 μm), followed by inlay implantation onto the stromal bed over the pupillary center and covered by the corneal flap. Follow-up was 5 years. Main Outcome Measures: We measured UCVA and BCVA; patients underwent, slit-lamp examination, pachymetry, and confocal microscopy. The follow-up was up to 6 years. Results: The UCVA improved during 3 months and was stable for up to 2 years. There was a loss of ≥2 lines of spectacle-corrected visual acuity in 35% of eyes at 2 years, and a loss of ≥2 lines in 55.5% of the eyes at 5 years. Refractive predictability was poor, with 60% of the eyes having ±3.00 D of emmetropia. A decentration of the inlay occurred in 29.4%, progressive perilenticular deposits were observed in 88.2%, haze was seen in 73.5%, and the inlay was explanted in 58.8%, with a cumulative survival rate of 58.4%. Conclusions: An intracorneal inlay may be an option to treat hyperopia, but the tested inlay caused significant visual loss and scarring and had to be explanted in the majority of cases. Financial Disclosure(s): The authors have no proprietary or commercial interest in any of the materials discussed in this article. [Copyright &y& Elsevier]