Five-Year Follow-up of 399 Phakic Artisan–Verisyse Implantation for Myopia, Hyperopia, and/or Astigmatism

Purpose To report long-term results of Artisan–Verisyse phakic intraocular lenses (PIOLs) to correct myopia, hyperopia, and/or astigmatism and the percentage of additional keratorefractive surgery to eliminate residual refractive errors. Design Retrospective, nonrandomized, interventional case series. Participants From January 1996 to January 2003, 399 Artisan–Verisyse PIOLs were consecutively implanted. To correct myopia, 101 5-mm optic Verisyse PIOLs (group 1) and 173 6-mm optic Verisyse PIOLs (group 2) were implanted. Forty-one were PIOLs for hyperopia (group 3), and 84 were toric (group 4). Methods Manifest refraction, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), biomicroscopy, tonometry, funduscopy, and central endothelial cell count (ECC) were determined before surgery, at 3 months, and at yearly intervals up to 5 years. Main Outcome Measures Refraction, UCVA, BSCVA, efficacy and safety indexes, enhancements' rate with keratorefractive surgery, central ECC, and complications. Results Mean follow-up was 4.05 years. Mean preoperative spherical equivalent (SE) and that at last follow-up were, respectively, −19.8±3.23 and −0.5 ± 0.89 diopters (D) (group 1), −11.27±3.11 and −0.64±0.8 D (group 2), +4.92±1.7 and +0.02±0.51 D (group 3), and −6.82±8.69 and −0.09±0.64 D (group 4). Group 4 had a mean preoperative cylinder of −3.24±1.02 D, which decreased to −0.83±0.74 D postoperatively. Additional keratorefractive surgery was performed in 60.39% of eyes (group 1), 19.6% (group 2), 41.4% (group 3), and 5.95% (group 4). Mean preoperative central ECC and that at last follow-up were, respectively, 2836±398 and 2514±529 cells/mm2 (group 1), 2755±362 and 2454±588 cells/mm2 (group 2), 2735±355 and 2560±335 cells/mm2 (group 3), and 2632±543 and 2537±615 cells/mm2 (group 4). Main complications were 3 explantations due to an unacceptable drop in ECC, 3 lenses' repositioning (2 ocular trauma and 1 unappropriate iris capture), 3 lenses' exchange due to refractive errors, 1 macular hemorrhage, 1 retinal detachment, and 2 cataracts. Conclusions According to our experience, implantation of iris-claw PIOLs is a reversible, effective, stable, safe procedure in the first 5 years of follow-up.