Artiflex Toric foldable phakic intraocular lens: short-term results of a prospective European multicenter study.

PURPOSE: To evaluate the short-term efficacy, predictability, stability, and safety of the foldable Artiflex Toric phakic intraocular lens (pIOL; Ophtec) for the correction of myopia with astigmatism.

DESIGN

Prospective, nonrandomized multicenter study.

METHODS

One hundred fifteen eyes of 73 patients were implanted with an Artiflex Toric pIOL. Mean implanted spherical and cylindrical powers were -7.10 ± 2.70 diopters (D) and -2.14 ± 0.80 D, respectively. Total follow-up was 6 months. Outcome parameters included uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), subjective manifest refraction (used for vector analysis), intraocular pressure, and endothelial cell density (ECD).

RESULTS

At 6 months, 99.0% of eyes had a UCVA of ≥20/40, and 81.8% of eyes were ±0.5 D of the intended refraction. In 74.5% postoperative UCVA was equal to or better than preoperative BSCVA; 2 eyes lost 2 or more lines of BSCVA postoperatively because of the development of synechiae. In 75.5% of eyes the remaining cylinder was ±0.5 D. There was a significant decrease in ECD after 3 months (4.8% ± 11.9%), with no additional decline between 3 and 6 months. There were few complications, except for the incidence of pigment and nonpigment precipitates (14.8% and 12.2%, respectively at 6 months). Mean misalignment was 0.6 ± 1.5 degrees (range 0-8).

CONCLUSIONS

The Artiflex Toric pIOL effectively and safely corrects myopia and astigmatism in the short term, with stable and predictable visual results after 6 months, when strict inclusion criteria are applied. Deposition of pigment and nonpigment precipitates on the pIOL warrants further investigation.