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.