Clinical and patient-reported outcomes of bilateral implantation of a +2.5 diopter multifocal intraocular lens.
To assess the effectiveness and safety of a multifocal intraocular lens (IOL) with +2.5 diopter (D) additional power compared with a monofocal IOL.



Fifteen sites in the United States.



Prospective randomized patient- and observer-masked clinical trial.



Randomized patients received multifocal or monofocal IOLs bilaterally. Visual acuity (33 cm, 40 cm, 53 cm, 60 cm, 4 m) was measured; safety was assessed through adverse event rates. Patient-reported visual outcomes were evaluated using the Visual Tasks questionnaire. The frequency and severity of visual disturbances were evaluated using the Assessment of Photic Phenomena and Lens EffectS questionnaire.



The multifocal IOL (n = 155) provided better corrected distance visual acuity at 53 cm than the monofocal IOL (n = 165) (0.322 versus 0.512 logMAR; between-group difference, -0.190 logMAR; P < .0001) and 40 cm but not at 4 m. Ocular adverse event rates were less than 3.84% in both groups. Serious adverse event rates were comparable between the 2 IOL types. Patients with multifocal IOLs reported less difficulty with near tasks (with and without correction) and intermediate tasks (without correction). Difficulty with extended-intermediate and distance tasks was similar between groups. The most frequently reported self-rated severe phenomena were halos, starbursts, and glare. Most patients (monofocal ≥72%; multifocal ≥73%) reported never experiencing blurred, distorted, or double vision.



The +2.5 D multifocal IOL provided better vision at 40 cm and 53 cm and similar vision at 4 m compared with the monofocal IOL. Safety profiles and visual phenomena were comparable between groups.
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA. Electronic address: amaxwellmd@gmail.com.
Andrew
A
Maxwell
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Edward
E
Holland
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Lisa
L
Cibik
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Anna
A
Fakadej
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Gary
G
Foster
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Les
L
Grosinger
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Andrew
A
Moyes
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Stephen
S
Nielsen
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Steven
S
Silverstein
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Melissa
M
Toyos
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Arthur
A
Weinstein
From the California Eye Institute (Maxwell), Fresno, California; Cincinnati Eye Institute (Holland), Cincinnati, Ohio; Associates in Ophthalmology (Cibik), West Mifflin and the Eye Center of Central PA (Hartzell), Allenwood, Pennsylvania; Carolina Eye Associates, PA (Fakadej), Southern Pines, North Carolina; Eye Center of Northern Colorado, PC (Foster), Fort Collins, Colorado; Grosinger, Spigelman & Grey Eye Surgeons, PC (Grosinger), Bloomfield Hills, Michigan; Moyes Eye Center, PC (Moyes) and Silverstein Eye Centers (Silverstein), Kansas City, Missouri; Nielsen Eye Center (Nielsen), Quincy, Massachusetts; Toyos Clinic (Toyos), Nashville, Tennessee; Eye Associates of New Mexico (Weinstein), Albuquerque, New Mexico, USA.
Scott
S
Hartzell
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D019466:Glare; D006801:Humans; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D000075542:Multifocal Intraocular Lenses; D000071066:Patient Reported Outcome Measures; D017060:Patient Satisfaction; D018918:Phacoemulsification; D011446:Prospective Studies; D019591:Pseudophakia / Q000503:physiopathology*; D011795:Surveys and Questionnaires; D015348:Vision, Binocular / Q000502:physiology; D014792:Visual Acuity / Q000502:physiology*