Packer M, et al. - Authors assessed the safety and efficacy of the enVista One-Piece Hydrophobic Acrylic MX60T Toric IOL (enVista MX60T Toric IOL) in this prospective, multicenter, partially randomized, partially controlled, double-masked, pivotal study. For patients with preoperative corneal astigmatism undergoing IOL implantation, enVista MX60T Toric IOL was safe and effective.

Methods

• Experts evaluated the subjects (n=191) that were implanted with the enVista MX60T Toric IOL (cylinder powers 1.25, 2.00, or 2.75 D) or the parent MX60 IOL (control).
• They randomized the eyes within the lowest range of corneal astigmatism to receive either Toric 1.25 D IOL or control IOL in a 1:1 ratio.
• Toric IOLs were received by all subjects with corneal astigmatism requiring 2.00 or 2.75 D cylinder IOLs.
• The primary effectiveness endpoints measured at Visit 4 were rotational stability, cylinder reduction, and best-corrected distance visual acuity (120–180 days postoperatively).

Results

• As per data, in the All Toric group visit 4 mean absolute axis misalignment was 4.68°±7.33°, and all subjects had ≤5° absolute rotation from Visit 3 to Visit 4.
• Findings suggested that compared to control at Visit 4, the 1.25 D group had significantly greater improvement in dioptric cylinder reduction (P < 0.001), percent cylinder reduction (P < 0.001), and mean uncorrected distance visual acuity (P < 0.001).
• In the study eyes, most adverse events (AEs) were mild, with no serious AEs.
• For Standardization (ISO) standard 11979-7 AE rates, the rates of cumulative AEs through Visit 4 were below International Organization.