Clinical results with the Medennium phakic refractive lens for the correction of high myopia

Abstract

Purpose To evaluate the predictability, safety, stability, complications, and biocompatibility of the phakic refractive lens (PRL) as a posterior chamber intraocular lens to correct high myopia. Methods Fifty eyes of 31 patients who underwent posterior chamber PRL implantation were evaluated prospectively. Mean preoperative myopia was -12.54 +/- 4.22 diopters (D) (range: -4.50 to -23.50 D) and mean astigmatic refractive power was -1.38 +/- 1.24 D (range: -1.00 to -4.50 D). Surgical implantation was performed through a 3.0- to 4.0-mm clear cornea sutureless incision using parabulbar (sub-Tenon's) anesthesia. Intra- and postoperative complications were recorded. Results Three months after surgery, the mean spherical equivalent refraction was -0.21 +/- 0.42 D (range: +1.00 to -1.75 D). At 6 and 12 months, mean spherical equivalent refraction was -0.23 +/- 0.38 D (range: 0 to -1.25 D). At the last examination, uncorrected visual acuity was > or = 20/40 in 41 (82%) eyes and > or = 20/20 in 22 (44%) eyes. Best spectacle-corrected visual acuity (BSCVA) was > or = 20/40 in 42 (84%) eyes and > or = 20/20 in 27 (54%) eyes. Comparison of pre- and postoperative BSCVA at 12 months showed that 12 (36.4%) of 33 eyes gained > or =1 lines of BSCVA and 7 (21.2%) of 33 eyes gained > or =2 lines. One (2%) eye developed anterior subcapsular cataract requiring lens exchange, and 1 (2%) eye developed acute angle closure glaucoma requiring YAG-iridotomy. One (2%) eye developed macular hemorrhage. Conclusions At 6 months and 1 and 2 years, PRL implantation yielded encouraging visual and refractive results with excellent biocompatibility. The efficacy, stability, and short-term safety of this lens was established. Serious complications, such as cataract and acute angle closure glaucoma, may occur, and long-term safety needs to be evaluated.