European multicenter study of the AcrySof ReSTOR apodized diffractive intraocular lens.
OBJECTIVE
To report the safety and effectiveness of the AcrySof ReSTOR apodized diffractive intraocular lens (IOL), model MA60D3, when implanted into the capsular bag.


METHODS
Multicenter European study including university clinics, eye hospitals, and private ophthalmic surgical centers.


METHODS
One hundred twenty-seven subjects implanted in cataractous eyes in an open multicenter study.


METHODS
After phacoemulsification, the foldable 3-piece hydrophobic acrylic apodized diffractive IOL was implanted in the capsular bag using a Monarch injector with an A-cartridge. The mean preoperative patient age was 68.4+/-12 years. Intraocular lens implant power ranged from 18.0 to 25.0 diopters (D) in 0.5-D increments.


METHODS
Distance visual acuity (VA), near VA, spectacle dependence, unwanted visual symptoms, and patient satisfaction.


RESULTS
At the 6-month postoperative visit, binocular (both eyes simultaneously) mean uncorrected distance and near logarithm of the minimum angle of resolution VAs for the MA60D3 were 0.04+/-0.14 and 0.09+/-0.12 (n = 118), respectively. In addition, 88.0% and 84.6% of ReSTOR subjects achieved spectacle independence for distance and near vision, respectively. Glare and halos were reported as severe by only 8.5% and 4.2% of patients, respectively. Ninety-two percent of patients stated that they would choose to have the same lens implanted again after the first implant, and 95.7% answered likewise after the second implant.


CONCLUSIONS
The AcrySof ReSTOR MA60D3 IOL demonstrated excellent near VA without compromising distance vision. Spectacle independence and patient satisfaction were high, whereas unwanted photic phenomena were clinically acceptable.
Department of Ophthalmology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany. kohnen@em.uni-frankfurt.de
Thomas
T
Kohnen
David
D
Allen
Catherine
C
Boureau
Philippe
P
Dublineau
Christian
C
Hartmann
Ekkehard
E
Mehdorn
Pascal
P
Rozot
Giorgio
G
Tassinari
D000180:Acrylic Resins; D000368:Aged; D005060:Europe; D005139:Eyeglasses / Q000706:statistics & numerical data; D005260:Female; D019466:Glare; D006801:Humans; D019654:Lens Implantation, Intraocular; D007910:Lenses, Intraocular / Q000009:adverse effects; D008297:Male; D017060:Patient Satisfaction; D018918:Phacoemulsification; D011474:Prosthesis Design; D011788:Quality of Life; D015348:Vision, Binocular / Q000502:physiology; D014792:Visual Acuity / Q000502:physiology*
D000180:Acrylic Resins