Phakic refractive lens: two-year results.

PURPOSE: To evaluate the surgical outcome and adverse events associated with correction of myopia and hyperopia with a phakic refractive lens (PRL), and to determine the random errors of the analytical methods used in the trial.

METHODS: In this prospective clinical study, 14 myopic and 6 hyperopic PRLs were implanted in 20 eyes of 20 patients from April to November 2002. Follow-up included evaluation of the PRL rotation with retroillumination photography, the distance between the PRL and crystalline lens with Scheimpflug images, laser flare meter, endothelial cell count, uncorrected (UCVA) and best spectacle-corrected visual acuity (BSCVA), refraction, intraocular pressure, and induced cataract. The random errors of the measurements with laser flare meter were 17%, with Scheimpflug images 10%, and with endothelial cell count 2.8%.

RESULTS: Postoperatively, 25% of eyes gained 2 or more lines and no eye lost 2 or more lines of BSCVA. Mean UCVA was 0.89 +/- 0.34. Laser flare values returned to baseline at 3 months and had no changes at 1 or 2 years (P > .05). The PRL rotated less during the second year than the first year. The distance between the PRL and crystalline lens was less at 1 year than at baseline (P < .05) but had no change during the second year. No statistically significant endothelial cell loss was noted between 1 week and 1 or 2 years postoperatively (P > .05). Two (10%) eyes developed pupillary block, one (5%) hyperopic eye showed unexpected postoperative myopia, and in another hyperopic eye (5%) the horizontal iris transillumination defects were noticed at 1 year combined with slight pupil ovalization at 2 years. No induced cataract, glaucoma, or inflammation was observed.

CONCLUSIONS: Safety and efficacy indexes were high at 2-year follow-up. The distance between the PRL and crystalline lens decreased by 59% during the first year but seemed to stabilize thereafter. The PRL rotated in only a few eyes after the first year.