Clinical results of ZSAL-4 angle-supported phakic intraocular lenses in 190 myopic eyes

PURPOSE: To evaluate the efficacy and safety of angle-supported phakic intraocular lenses (IOLs) in myopia. SETTING: Private practice, Siena, Italy. METHODS: This prospective noncomparative single-surgeon interventional case series comprised 190 consecutive myopic eyes of 115 patients having implantation of a ZSAL-4 IOL (Morcher GmbH) through a 5.5 mm x 3.0 mm sclerocorneal tunnel along the steepest meridian with a surgical iridectomy. Preoperatively, the mean spherical equivalent was -14.37 diopters (D) +/- 4.40 (SD) and the mean astigmatism, 1.66 +/- 1.36 D. RESULTS: Postoperatively, the mean defocus equivalent (DEQ) was 1.55 +/- 1.06 D and the mean astigmatism, 1.41 +/- 1.11 D. The mean surgically induced astigmatism (vector analysis) was 1.03 +/- 0.77 D (95% confidence interval [CI], 0.92 to 1.15); 146 eyes (77%) were within +/-2.0 D of the DEQ, 76 eyes (40%) were within +/-1.0 D, and 36 eyes (19%) were within +/-0.5 D. The safety index was 1.25 and the efficacy index, 0.78. The improvement in best spectacle-corrected visual acuity (0.17) was statistically significant (95% CI, 0.14 to 0.2). Complications were intraocular pressure spike due to topical steroids, 18%; chronic iridocyclitis, 1%; explantation of unstable IOL, 1%; explantation of IOL for iridocyclitis, 0.5%; pupil ovalization, 11%; halos, 18%; and macular hemorrhage, 1%. CONCLUSIONS: Angle-supported IOLs can effectively correct high myopia, although residual refractive errors may require secondary procedures. The main intraoperative and postoperative complications were halos, steroid response, and incorrect IOL sizing. The role of surgery in inducing macular hemorrhages should be assessed further.