Five Year Endothelial Cell Loss after Implantation with Artiflex Myopia and Artiflex Toric Phakic Intraocular Lenses

PURPOSE: To evaluate the long-term changes in endothelial cell density (ECD) after the implantation of two types of foldable iris-fixated phakic intraocular lenses (pIOLs) for the treatment of myopia and astigmatism.

DESIGN: Prospective clinical cohort study.

METHODS: Two-hundred-and-ninety-three and 188 eyes implanted with the Artiflex Myopia and Artiflex Toric (Ophtec B.V., Groningen, the Netherlands) iris-fixated pIOL for the treatment of myopia or astigmatism at the University Eye Clinic Maastricht as of January 2004. One-hundred-and-forty-six eyes from the myopic and 64 eyes from the toric groups completed a 5 year follow-up. Main outcome measures were chronic endothelial cell (EC) loss, percentage of eyes with a ≥25% decrease in ECD and the percentage of eyes with an ECD <1500 cells/mm2.

RESULTS: Chronic EC loss showed an annual decline of 64 cells/mm2 in the myopic (p<0.001, standard error 3.58) and 62 cells/mm2 in the toric (p<0.001, standard error 3.77) groups. Total chronic EC loss from 6 months to 5 years postoperatively was 10.5% in the myopic and 10.2% in the toric groups. After 5 years, an ECD decrease of ≥25% occurred in 4.4% and 4.3% of eyes, and an ECD <1500 cells/mm2 was reported in 3.0% and 0.0% of eyes, respectively. Explantation of a pIOL due to EC loss was required in 3.1% and 0% of eyes.

CONCLUSION: Chronic EC loss was around 10% over a 5 year period in eyes implanted with the foldable myopic (toric) pIOL. In up to 3.1% of eyes significant EC loss resulted in subsequent pIOL explantation.