OBJECTIVE To confirm the safety, efficacy, and predictability of the surgical correction of myopia and hyperopia with the phakic refractive lens (PRL) (Medennium Inc.). METHODS St. Eriks Eye Hospital, Stockholm, Sweden. METHODS This was a prospective clinical study of 20 eyes, 14 myopic and 6 hyperopic, that had PRL implantation at St. Eriks Eye Hospital from April to November 2002. Examinations were performed preoperatively and 1 day, 1 week, 3 months, and 1 year postoperatively. Follow-up included evaluation of the PRL rotation with retroillumination photography, evaluation of the distance between the PRL and the crystalline lens with Scheimpflug image, laser flare, endothelial cell count, uncorrected (UCVA) and best corrected (BCVA) visual acuity, residual refractive error, refractive stability, intraocular pressure, and induced cataract. RESULTS Postoperatively, 11 eyes (55%) gained 1 or more lines, 5 eyes (25%) had no change, and 4 eyes (20%) lost 1 line of BCVA. No eye lost 2 or more lines. Mean UCVA was 0.87+/- 0.29 postoperatively. Laser flare values were highest 1 day after operation with normalization at 3 months and without changes at 1 year (P<.05). A rotation of 10 degrees or more was found in 15 eyes (75%) during the first year. The distance between the PRL and crystalline lens was considerably less at 1 year than at baseline (P<.05). There was no statistically significant endothelial cell loss induced by the PRL (P<.05). No induced cataract, glaucoma, or inflammation was observed. In 1 hyperopic eye, horizontal iris transillumination defects were noticed at 1 year. CONCLUSIONS Safety and efficacy indexes were high at 1-year follow-up. The PRL rotated slightly in the posterior chamber. The distance between the PRL and the crystalline lens was considerably less at 1 year than at baseline.