Objective: To evaluate efficiency, predictability, stability, complications, and patient satisfaction after implantation of a foldable iris-fixated phakic intraocular lens (PIOL) for the correction of myopia.

Design: Prospective, nonrandomized, comparative (self-controlled) trial.

Participants: Forty-one eyes of 22 myopic patients aged 18 to 56 years (mean, 36 years) with average sphere of -8.2+/-2.01 diopters (D; range, -12.25 to -3.75 D) and average preoperative cylinder of -0.90+/-0.62 D (range, -2.50 to 0.00 D) were enrolled in this prospective study.

Methods: All eyes underwent implantation of a foldable iris-fixated PIOL with an optical zone of 6.0 mm. The follow-up was 6 months in all cases. Phakic intraocular lenses were available in powers ranging from -2.0 D to -12.0 D.

Main Outcome Measures: The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity, refraction, endothelial cell count, intraocular pressure, slit-lamp biomicroscopy, and indirect ophthalmoscopy.

Results: At 6 months' follow-up, no eyes experienced a loss in BSCVA and 78% gained 1 or more lines of their preoperative BSCVA. Uncorrected visual acuity was significantly improved, with 82% of eyes reaching 20/25 or better. There was a significant reduction in spherical errors in all patients after surgery. Ninety-one percent of eyes were within +/-0.50 D of target refraction. A slight loss of endothelial cells (2.3 %) was observed 6 months after surgery. There were no intraoperative complications. In the postoperative follow-up, however, pigment precipitates were noted in 5 eyes of 4 patients.

Conclusions: At short-term follow-up, the implantation of the foldable iris-fixated PIOL proved to be effective and predictable for the correction of myopia in phakic eyes. However, longer follow-up with larger numbers of patients is necessary to evaluate long-term complications.

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http://dx.doi.org/10.1016/j.ophtha.2005.06.036DOI Listing

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