Phakic refractive lens (Medennium) for correction of +4.00 to +6.00 diopters: 1-year follow-up

PURPOSE: To study the efficacy and safety of phakic refractive lens (PRL) implantation to correct high hyperopia. METHODS: Inclusion criteria for this prospective, observer-masked, interventional study were spherical equivalent > or =+4.00 diopters (D) of cycloplegic hyperopia, best spectacle-corrected visual acuity (BSCVA) > or =0.5, anterior chamber depth > or =3 mm, and mesopic pupil size < or =6 mm. Lenses were implanted in all cases under regional anesthesia using forceps. RESULTS: Sixteen eyes of nine patients were included in the study. Mean preoperative spherical equivalent refraction was +5.65+/-1.41 D (range: +3.25 to +5.75 D). Mean 1-year postoperative spherical equivalent refraction was +0.07+/-0.43 D (range: -0.50 to 0.75 D). Fifteen (93.75%) eyes were within +/-0.50 D of emmetropia, and 16 (100%) eyes were within +/-1.00 D of emmetropia. Safety and efficacy indexes were 0.9 and 0.8, respectively. Eight (50%) eyes needed LASIK to correct residual astigmatism. Five (31.25%) eyes lost one line of BSCVA; no eye lost two or more lines of BSCVA. The BSCVA did not increase in any eye. No significant intraocular complications developed. CONCLUSIONS: Phakic refractive lens implantation to correct high hyperopia seems to be a safe and accurate procedure. A mild but significant loss in BSCVA can be anticipated.