title: Bilateral implantation of +2.5 D multifocal intraocular lens and contralateral implantation of +2.5 D and +3.0 D multifocal intraocular lenses: Clinical outcomes.
abstract: OBJECTIVE
  To assess the clinical visual outcomes of bilateral implantation of Restor +2.5 diopter (D) multifocal intraocular lenses (IOLs) and contralateral implantation of a Restor +2.5 D multifocal IOL in the dominant eye and Restor +3.0 D multifocal IOL in the fellow eye.
  
  
  METHODS
  Multicenter study at 8 investigative sites.
  
  
  METHODS
  Prospective randomized parallel-group patient-masked 2-arm study.
  
  
  METHODS
  This study comprised adults requiring bilateral cataract extraction followed by multifocal IOL implantation. The primary endpoint was corrected intermediate visual acuity (CIVA) at 60 cm, and the secondary endpoint was corrected near visual acuity (CNVA) at 40 cm. Both endpoints were measured 3 months after implantation with a noninferiority margin of Δ = 0.1 logMAR.
  
  
  RESULTS
  In total, 103 patients completed the study (53 bilateral, 50 contralateral). At 3 months, the mean CIVA at 60 cm was 0.13 logMAR and 0.10 logMAR in the bilateral group and contralateral group, respectively (difference 0.04 logMAR), achieving noninferiority. Noninferiority was not attained for CNVA at 40 cm; mean values at 3 months for bilateral and contralateral implantation were 0.26 logMAR and 0.11 logMAR, respectively (difference 0.15 logMAR). Binocular defocus curves suggested similar performance in distance vision between the 2 groups. Treatment-emergent ocular adverse events rates were similar between the groups.
  
  
  CONCLUSIONS
  Bilateral implantation of the +2.5 D multifocal IOL resulted in similar distance as contralateral implantation of the +2.5 D multifocal IOL and +3.0 D multifocal IOL for intermediate vision (60 cm), while noninferiority was not achieved for near distances (40 cm).
authors.affiliation: From the University Eye Clinic (Nuijts, Jonker), Maastricht University Medical Center, Maastricht, and the Ophthalmology Department (Lapid-Gortzak), Academic Medical Center, Amsterdam, the Netherlands; Kaufer Clinica de Ojos (Kaufer), Buenos Aires, Argentina; Servicio de Oftalmologia (Mendicute), Hospital Universitario Donostia, San Sebastian, and the Fundacion Oftalmologica del Mediterraneo (Martinez), Valencia, Spain; Augen-Zentrum-Nordwest (Schmickler), Ahaus, and the Department of Ophthalmology (Kohnen), Goethe-University, Frankfurt, Germany.
authors.forename: Rudy M M A
authors.initials: RM
authors.lastname: Nuijts
authors.affiliation: From the University Eye Clinic (Nuijts, Jonker), Maastricht University Medical Center, Maastricht, and the Ophthalmology Department (Lapid-Gortzak), Academic Medical Center, Amsterdam, the Netherlands; Kaufer Clinica de Ojos (Kaufer), Buenos Aires, Argentina; Servicio de Oftalmologia (Mendicute), Hospital Universitario Donostia, San Sebastian, and the Fundacion Oftalmologica del Mediterraneo (Martinez), Valencia, Spain; Augen-Zentrum-Nordwest (Schmickler), Ahaus, and the Department of Ophthalmology (Kohnen), Goethe-University, Frankfurt, Germany. Electronic address: soraya.jonker@mumc.nl.
authors.forename: Soraya M R
authors.initials: SM
authors.lastname: Jonker
authors.affiliation: From the University Eye Clinic (Nuijts, Jonker), Maastricht University Medical Center, Maastricht, and the Ophthalmology Department (Lapid-Gortzak), Academic Medical Center, Amsterdam, the Netherlands; Kaufer Clinica de Ojos (Kaufer), Buenos Aires, Argentina; Servicio de Oftalmologia (Mendicute), Hospital Universitario Donostia, San Sebastian, and the Fundacion Oftalmologica del Mediterraneo (Martinez), Valencia, Spain; Augen-Zentrum-Nordwest (Schmickler), Ahaus, and the Department of Ophthalmology (Kohnen), Goethe-University, Frankfurt, Germany.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Kaufer
authors.affiliation: From the University Eye Clinic (Nuijts, Jonker), Maastricht University Medical Center, Maastricht, and the Ophthalmology Department (Lapid-Gortzak), Academic Medical Center, Amsterdam, the Netherlands; Kaufer Clinica de Ojos (Kaufer), Buenos Aires, Argentina; Servicio de Oftalmologia (Mendicute), Hospital Universitario Donostia, San Sebastian, and the Fundacion Oftalmologica del Mediterraneo (Martinez), Valencia, Spain; Augen-Zentrum-Nordwest (Schmickler), Ahaus, and the Department of Ophthalmology (Kohnen), Goethe-University, Frankfurt, Germany.
authors.forename: Ruth
authors.initials: R
authors.lastname: Lapid-Gortzak
authors.affiliation: From the University Eye Clinic (Nuijts, Jonker), Maastricht University Medical Center, Maastricht, and the Ophthalmology Department (Lapid-Gortzak), Academic Medical Center, Amsterdam, the Netherlands; Kaufer Clinica de Ojos (Kaufer), Buenos Aires, Argentina; Servicio de Oftalmologia (Mendicute), Hospital Universitario Donostia, San Sebastian, and the Fundacion Oftalmologica del Mediterraneo (Martinez), Valencia, Spain; Augen-Zentrum-Nordwest (Schmickler), Ahaus, and the Department of Ophthalmology (Kohnen), Goethe-University, Frankfurt, Germany.
authors.forename: Javier
authors.initials: J
authors.lastname: Mendicute
authors.affiliation: From the University Eye Clinic (Nuijts, Jonker), Maastricht University Medical Center, Maastricht, and the Ophthalmology Department (Lapid-Gortzak), Academic Medical Center, Amsterdam, the Netherlands; Kaufer Clinica de Ojos (Kaufer), Buenos Aires, Argentina; Servicio de Oftalmologia (Mendicute), Hospital Universitario Donostia, San Sebastian, and the Fundacion Oftalmologica del Mediterraneo (Martinez), Valencia, Spain; Augen-Zentrum-Nordwest (Schmickler), Ahaus, and the Department of Ophthalmology (Kohnen), Goethe-University, Frankfurt, Germany.
authors.forename: Cristina Peris
authors.initials: CP
authors.lastname: Martinez
authors.affiliation: From the University Eye Clinic (Nuijts, Jonker), Maastricht University Medical Center, Maastricht, and the Ophthalmology Department (Lapid-Gortzak), Academic Medical Center, Amsterdam, the Netherlands; Kaufer Clinica de Ojos (Kaufer), Buenos Aires, Argentina; Servicio de Oftalmologia (Mendicute), Hospital Universitario Donostia, San Sebastian, and the Fundacion Oftalmologica del Mediterraneo (Martinez), Valencia, Spain; Augen-Zentrum-Nordwest (Schmickler), Ahaus, and the Department of Ophthalmology (Kohnen), Goethe-University, Frankfurt, Germany.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schmickler
authors.affiliation: From the University Eye Clinic (Nuijts, Jonker), Maastricht University Medical Center, Maastricht, and the Ophthalmology Department (Lapid-Gortzak), Academic Medical Center, Amsterdam, the Netherlands; Kaufer Clinica de Ojos (Kaufer), Buenos Aires, Argentina; Servicio de Oftalmologia (Mendicute), Hospital Universitario Donostia, San Sebastian, and the Fundacion Oftalmologica del Mediterraneo (Martinez), Valencia, Spain; Augen-Zentrum-Nordwest (Schmickler), Ahaus, and the Department of Ophthalmology (Kohnen), Goethe-University, Frankfurt, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kohnen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015350:Contrast Sensitivity / Q000502:physiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D019654:Lens Implantation, Intraocular; D007910:Lenses, Intraocular; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000503:physiopathology / Q000601:surgery*; D017060:Patient Satisfaction; D018918:Phacoemulsification; D011446:Prospective Studies; D011474:Prosthesis Design; D019591:Pseudophakia / Q000503:physiopathology; D011795:Surveys and Questionnaires; D014792:Visual Acuity / Q000502:physiology