Five-year follow-up of 399 phakic Artisan-Verisyse implantation for 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/mm(2) (group 1), 2755 +/- 362 and 2454 +/- 588 cells/mm(2) (group 2), 2735 +/- 355 and 2560 335 cells/mm(2) (group 3), and 2632 +/- 543 and 2537 +/- 615 cells/mm(2) (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.