Because of the incomplete follow-up, we cannot draw conclusions about the long-term safety of the implantable contact lens. The intimate contact between the contact lens and the natural lens raises the possibility of cataract formation. However, examination by Scheimpflug photography and ultrasound biomicroscopy showed no progressive lens opacities.
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 ≥ 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. [J Refract Surg. 2005;21:116-126.]
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