NOV 30, 2010
This randomized subject-masked study compared the safety and efficacy of Alcon's AcrySof Toric IOL with those of a spherical IOL in subjects with cataract and pre-existing corneal astigmatism. They conclude that the one-year results demonstrate favorable results in terms of efficacy, rotational stability, freedom from spectacles and safety.
The authors randomized 517 patients to undergo unilateral implantation with an AcrySof Toric IOL (models SA60T3, SA60T4 or SA60T5) or an AcrySof spherical IOL (SA60AT). Spherical power ranged from 12.00 to 25.00 D. Cylinder powers were 1.50, 2.25 or 3.00 D for corneal astigmatism correction of 0.75 to < 1.50, ≥ 1.50 to < 2.00 and ≥ 2.00 D with no upper limit, respectively. No limbal relaxing incisions were permitted.
At one year postop, 77.7 percent of eyes in the toric group achieved 20/20 or better best spectacle-corrected distance visual acuity compared with 69.2 percent of controls. UDVA of 20/20 or better was achieved in 40.7 percent of toric IOL eyes versus 19.4 percent of control IOL eyes (P < 0.05).
Mean absolute residual refractive cylinder was 0.59 D with the toric IOL versus 1.22 D with the control IOL (P < 0.0001). Mean rotation was < 4° (range, 0° to 20°) for the toric IOL. The authors say that the low incidence of rotation observed in this study with the AcrySof Toric IOL (≥ 15°, 1.2 percent) may be attributable to its biomaterial, which has demonstrated adhesive properties.
Sixty-one percent of toric IOL eyes achieved spectacle freedom at six months versus 36.4 percent of control IOL eyes (P < 0.0001). There were few complications in either group.