Safety and effectiveness of a new toric presbyopia-correcting posterior chamber silicone intraocular lens.

PURPOSE: To evaluate the safety and effectiveness of the Trulign toric intraocular lens (IOL) in adults with cataract. SETTING: Eight private practices in the United States and 1 in Canada. DESIGN: Prospective randomized single-masked multicenter study. METHODS: A toric IOL (1.25 D, 2.00 D, or 2.75 D, determined by a toric calculator) was implanted in eligible patients with age-related cataract requiring a 16.00 to 27.00 diopter (D) spherical IOL power and with a predicted postoperative astigmatism of 0.83 to 2.50 D. Eyes within the lowest cylinder range (predicted postoperative astigmatism 0.83 to 1.32 D) were randomized in a 1:1 ratio between the 1.25 D toric IOL group and the nontoric accommodating IOL (Crystalens) control group. RESULTS: The toric 1.25 D group had a statistically significantly greater percentage reduction in absolute cylinder (P < .001) and uncorrected distance visual acuity (P = .002) than the control group at the 120- to 180-day visit. The mean monocular uncorrected vision at distance, intermediate, and near was 20/25, 20/22, and 20/39, respectively, with the 1.25 D, 2.00 D, and 2.75 D toric IOLs in aggregate (toric group). In addition, 96.1% of patients (123/128) had 5.0 degrees or less absolute IOL rotation postoperatively. Regarding safety, the endpoints for preservation of corrected visual acuity and the incidence of complications and adverse events were met. CONCLUSION: The toric IOL was safe and effective in reducing the effects of preoperative corneal astigmatism and provided excellent uncorrected distance and intermediate vision and functional near vision. FINANCIAL DISCLOSURES: Dr. Pepose is a consultant to Bausch & Lomb and was medical monitor of this study. Drs. Buckhurst, Whitman, Feinerman, Hovanesian, Davies, Labor, and Carter are consultants to Bausch & Lomb. At the time of the study, Drs. Hayashida, and Khodai were employees of Bausch & Lomb. Drs. Colvard and Mittleman have financial or proprietary interest in any material or method mentioned.

Safety and effectiveness of a glistening-free single-piece hydrophobic acrylic intraocular lens (enVista).

PURPOSE: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA) when used to correct aphakia following cataract extraction in adults. METHODS: This was a prospective case series (NCT01230060) conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA)-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA) of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1) to have the lens implanted in one of four axis positions in 45° increments. RESULTS: A total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100%) achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive stability was demonstrated. A low evaluation of posterior capsule opacification score was demonstrated, and no glistenings of any grade were reported for any subject at any visit. CONCLUSION: This study demonstrated the safety and effectiveness of the MX60 IOL. Favorable clinical outcomes included preserved BCVA, excellent rotational and refractive stability, no glistenings, and a low evaluation of posterior capsule opacification score.