title: Safety and effectiveness of a new toric presbyopia-correcting posterior chamber silicone intraocular lens.
abstract: OBJECTIVE
  To evaluate the safety and effectiveness of the Trulign toric intraocular lens (IOL) in adults with cataract.
  
  
  METHODS
  Eight private practices in the United States and 1 in Canada.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  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.
authors: 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.
authors: Jay S
authors: JS
authors: Pepose
authors: 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.
authors: Jon
authors: J
authors: Hayashida
authors: 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.
authors: John
authors: J
authors: Hovanesian
authors: 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.
authors: James
authors: J
authors: Davies
authors: 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.
authors: Phillips Kirk
authors: PK
authors: Labor
authors: 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.
authors: Jeffrey
authors: J
authors: Whitman
authors: 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.
authors: Harvey
authors: H
authors: Carter
authors: 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.
authors: Michael
authors: M
authors: Colvard
authors: 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.
authors: Phillip J
authors: PJ
authors: Buckhurst
authors: 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.
authors: Omid
authors: O
authors: Khodai
authors: 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.
authors: David
authors: D
authors: Mittleman
authors: 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.
authors: Gregg
authors: G
authors: Feinerman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001251:Astigmatism / Q000601:surgery; D001672:Biocompatible Materials; D002386:Cataract / Q000150:complications; D004869:Equipment Safety; D005260:Female; D006801:Humans; D019654:Lens Implantation, Intraocular; D007910:Lenses, Intraocular; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification; D011305:Presbyopia / Q000150:complications / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D012029:Refraction, Ocular / Q000502:physiology; D012826:Silicone Elastomers; D016037:Single-Blind Method; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
chemical_list: D001672:Biocompatible Materials; D012826:Silicone Elastomers