Purpose: To evaluate the safety and efficacy of the iris claw phakic intraocular lens (Artisan; Ophtec BV, Groningen, The Netherlands) in patients with high myopia.
Methods: Between May 1999 and July 2001, 93 Artisan phakic intraocular lenses (IOLs) were implanted in 60 patients affected by high myopia. All patients underwent 24-month follow-up. The power of the lenses ranged from -7.5 to -22.0 diopters (D). Patients were divided into two groups: group 1 (68 eyes), myopia -6.75 to -15.50 D (SE), and group 2 (25 eyes), myopia -16.0 to -23.0 D (SE). Pre- and postoperative patient evaluation included manifest and cycloplegic refractions, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), endothelial cell count, intraocular pressure, complication rate, safety, and efficacy.
Results: At 4 months, 83.8% (57/68) (group 1, myopia -6.75 to -15.50 D) and 68% (17/25) (group 2, myopia -16.0 to -23.0 D) of eyes achieved UCVA of > or =20/40. The BSCVA remained the same or improved in 100% of eyes. After 4 months, 69.1% (47/68) of eyes in group 1 and 52% (13/25) of eyes in group 2 were within +/-1.00 D of the desired refraction; the mean refraction was stable between 4 and 24 months. Of the intraoperative complications, 69.2% were observed in the first 25 lenses implanted; postoperative complications included iris atrophy in 11.8% (11/93), lens decentration in 5.4% (5/93), and night glare in 6.4% (6/93) of eyes. No IOLs were removed. Mean endothelial cell loss was 2.8% at 4 months, 3.9% at 12 months, and 5.4% at 24 months.
Conclusions: Our results regarding implantation of the Artisan phakic IOL confirm that these lenses are safe and effective for the correction of high myopia, with a stable refractive outcome but with a higher than normal rate of endothelial cell loss during 2-year follow-up.