Rotational Stability and Visual Performance of Aberration-Free, Hydrophobic Acrylic Monofocal Toric IOL with Enhanced Material.

Abstract

Purpose: To evaluate the rotational stability and visual performance of the enVista toric intraocular lens (IOL) (MX60ET) in cataract patients with pre-existing astigmatism.

Setting: 6 US sites.

Design: Prospective, multicenter.

Methods: Cataract patients ≥18 years with pre-existing astigmatism (0.77 D to 4.53 D) underwent phacoemulsification and implantation of enVista toric IOL (MX60ET). Outcome measures were the proportion of patients with absolute IOL axis rotation of ≤5°, uncorrected and corrected distance visual acuities (UDVA and CDVA) at 4 m, uncorrected intermediate visual acuity (UIVA) at 66 cm, manifest refraction, and adverse events (AEs). The patients were followed up on Days 1-2, 7-14, 30-60, and 120-180.

Results: Mean astigmatism of 101 eyes (101 subjects) reduced from 1.47 ± 0.64 D preoperatively to 0.38 ± 0.38 D at Days 120-180 (p <0.001) with 88.1% (N=89/101) of eyes achieving astigmatism within 0.75 D. Mean postoperative UDVA and UIVA were 0.10 ± 0.16 and 0.25 ± 0.15 logMAR respectively. While 79.2% (N=80/101) of patients had postoperative UDVA of 20/32 or better, 63.9% (N=62/97) had UIVA of 20/40 or better. The mean toric IOL rotation from the operative visit to Days 30-60 was 1.97 ± 2.06° with 97.4% (N=74/76) of eyes showing toric IOL rotation of 5˚ or less.

Conclusion: The enhanced enVista toric IOL (MX60ET) demonstrated excellent rotational stability and astigmatic outcomes indicating good efficacy of the IOL for the correction of astigmatism during cataract surgery.