Purpose: To determine the 3-year follow-up of efficacy and safety of Artisan toric iris-fixated lens implantation after penetrating keratoplasty (PK) to correct high ametropia and astigmatism.
Design: Prospective noncomparative case series with a minimum follow-up of 1 year.
Participants: Artisan toric lens implantation was performed in 36 eyes of 35 patients who were contact lens intolerant or unable to wear glasses due to anisometropia and/or high astigmatism.
Intervention: Thirty-six eyes of 35 consecutive patients received Artisan toric lens implantation for postkeratoplasty astigmatism and/or anisometropia.
Main outcome measures: Manifest refraction, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), and corneal topography were determined or performed before surgery and at 3, 6, and 12 months and yearly intervals up to 4 years after surgery. Efficacy, safety, percent reduction of refractive astigmatism, anisometropia of defocus, and the astigmatism correction index were determined. A patient satisfaction questionnaire and specular microscopy were assessed.
Results: The mean +/- standard deviation of preoperative refractive cylinder was -7.06+/-2.01 diopters (D) (range, -3.0 to -11.0), which was reduced to -1.73+/-1.25 D, -1.69+/-1.15 D, -1.94+/-1.68 D, -2.02+/-1.93 D, and -2.00+/-1.53 D at 6 months (n = 36), 1 year (n = 36), 2 years (n = 29), 3 years (n = 15), and the last follow-up examination (28.5+/-12.5 months, n = 36), respectively (P<0.001 for all time points, paired t test). The spherical equivalent was reduced from -3.19+/-4.31 D (range, +5.5 to -14.25 D) preoperatively to -1.03+/-1.20 D (range, +1.0 to -5.25 D) at the last follow-up. The UCVA and BSCVA were > or =20/40 in 31.6% and 80.6%, respectively. There was a loss of BSCVA of >2 lines in 8.3% of eyes and a gain of at least 2 lines in 8.3% of eyes. Percent reductions in refractive astigmatism and anisometropia of defocus were 88.8%+/-29.5% and 77.8%+/-19.3%, respectively. The astigmatism correction index was 96.0%+/-24.2%. Satisfaction increased from 3.6 to 8.0 (scale, 0-10) after implantation. The endothelial cell loss as compared with preoperatively was 13.8%+/-18.7% (n = 34), 21.2%+/-21.8% (n = 33), 29.6%+/-27.3% (n = 26), 30.4%+/-32.0% (n = 18), and 34.8%+/-26.3% (n = 6) at 6 months (P = 0.001), 1 year (P<0.001), 2 years (P<0.001), 3 years (P = 0.001), and 4 years postoperatively (P = 0.1), respectively. In 2 patients, irreversible graft rejections occurred, and in 1 patient, gradual endothelial decompensation occurred.
Conclusion: Artisan toric lens implantation after PK was effective for reduction of refractive astigmatism and ametropia. All patients were suitable for spectacle correction after implantation. There was continuing endothelial cell loss from 6 months to 3 years postoperatively. In 3 cases, corneal graft failure developed.