Clinical Results With the Medennium Phakic Refractive Lens for the Correction of High Myopia

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.