Jay S Pepose1, Jon Hayashida2, John Hovanesian2, James Davies2, Phillips Kirk Labor2, Jeffrey Whitman2, Harvey Carter2, Michael Colvard2, Phillip J Buckhurst2, Omid Khodai2, David Mittleman2, Gregg Feinerman2. 1. From Pepose Vision Institute (Pepose) and the Department of Ophthalmology and Visual Sciences (Pepose), Washington University School of Medicine, St. Louis, Missouri, Bausch & Lomb (Hayashida, Khodai), Aliso Viejo, Harvard Eye Associates, (Hovanesian), Laguna Hills, Davies Eye Center (Davies), Carlsbad, Colvard-Kandavel Eye Center (Colvard), Encino, and Feinerman Vision Center (Feinerman), Newport Beach, California, Eye Consultants of Texas (Labor), Grapevine, Key-Whitman Eye Center (Whitman), and Carter Eye Center (Carter), Dallas, Texas, and Mittleman Eye Center (Mittleman), West Palm Beach, Florida, USA; Plymouth University (Buckhurst), Plymouth, United Kingdom. Electronic address: jpepose@peposevision.com. 2. From Pepose Vision Institute (Pepose) and the Department of Ophthalmology and Visual Sciences (Pepose), Washington University School of Medicine, St. Louis, Missouri, Bausch & Lomb (Hayashida, Khodai), Aliso Viejo, Harvard Eye Associates, (Hovanesian), Laguna Hills, Davies Eye Center (Davies), Carlsbad, Colvard-Kandavel Eye Center (Colvard), Encino, and Feinerman Vision Center (Feinerman), Newport Beach, California, Eye Consultants of Texas (Labor), Grapevine, Key-Whitman Eye Center (Whitman), and Carter Eye Center (Carter), Dallas, Texas, and Mittleman Eye Center (Mittleman), West Palm Beach, Florida, USA; Plymouth University (Buckhurst), Plymouth, United Kingdom.
Abstract
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.
RCT Entities:
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.