ABSTRACT
Purpose: To evaluate the safety, efficacy and potential risks of Artiflex foldable iris-fixated phakic intraocular lens (pIOL) implantation for the management of myopia. Materials and Methods: Seventy-eight eyes of 40 consecutive patients with a mean spherical refraction of –11.70 ± 3.77 diopters (D; range –5.50 to –17.5 D) were included in this prospective, noncomparative, interventional case series. Main parameters assessed were uncorrected visual acuity (UCVA), best-spectacle corrected visual acuity (BSCVA), corneal topography (Orbscan II, BauchandLomb, Rochester, NY, USA), manifest and cycloplegic refractive errors, endothelial cell density (ECD) and applanation tonometry. Results: After 2 years, BSCVA was 20/40 or better in 82% of the eyes and UCVA was 20/40 or better in 84% of the eyes. After 1 month, 1 year, and 2 years, 51.3% (37 of 72 eyes), 58.9% (46 of 78 eyes) and 76.0% (38 of 50 eyes) of eyes gained 1 line or more of BSCVA, respectively. Compared to preoperative values, the mean endothelial cell loss was 2.6% at 1 month, 4.9% at 1 year and 7.4% at 2 years. Pigmented or non-pigmented precipitates were observed in17 eyes (21.7%) which were treated with topical corticosteroids. At the second postoperative year, pigmented precipitates persisted in nine eyes. However, this was not associated with a loss of BSCVA. Conclusion: The implantation of Artiflex pIOL is an effective surgical option for the management of high myopia. The most common complication observed within 2 years of follow-up was accumulation of pigmented precipitates with no effect on the final BSCVA.