Cataract extraction with multifocal intraocular lens implantation: clinical, functional, and quality-of-life outcomes. Multicenter clinical trial in Germany and Austria.
OBJECTIVE
To compare bilateral implantation of a multifocal intraocular lens (IOL) versus a monofocal lens with respect to visual function, patient satisfaction, and quality of life.


METHODS
Seven clinical sites in Germany and 1 site in Austria.


METHODS
A prospective randomized masked clinical trial included 124 randomly assigned bilateral pseudophakic individuals, 64 of whom had bilateral implantation of an Array(R) foldable multifocal IOL (model SA-40N, Allergan) and 60 of whom had bilateral implantation of an AMO(R)PhacoFlex II(R) silicone monofocal IOL (model SI-40NB). Clinical data included binocular uncorrected and corrected distance and near visual acuities, complications, adverse events, and reports of halos and glare. Quality-of-life data were collected on 3 occasions using the modified Cataract TyPE Specification instrument. The functional status of the 2 groups was compared from baseline to final postoperative interview.


RESULTS
Three months after surgery, a higher proportion in the Array group achieved a Jaeger value of J3 (20/40 Snellen) or better uncorrected binocular near visual acuity and 0.5 (20/40) or better distance-corrected binocular near visual acuity than in the monofocal groups (97% versus 68% and 95% versus 59%, respectively; P <.001). A higher proportion in the multifocal group achieved both 0.5 (20/40) and J3 or better uncorrected binocular distance and near visual acuities (97% versus 66%; P <.001). Those in the Array group were more likely than those in the monofocal group to never wear glasses overall (41% versus 12%; P <.001). Multifocal patients rated their vision without glasses better overall, at near and at intermediate distances (P <.05), and demonstrated better visual function for near tasks and social activities.


CONCLUSIONS
Those who had bilateral implantation of the Array multifocal IOL obtained better uncorrected and distance-corrected near visual acuities and reported better overall vision, less limitation in visual function, and less spectacle dependency than patients with bilateral monofocal IOLs.
Javitt
J
J
Georgetown University School of Medicine and School of Public Health, Georgetown, Washington DC, USA.
Brauweiler
H P
HP
Jacobi
K W
KW
Klemen
U
U
Kohnen
S
S
Quentin
C D
CD
Teping
C
C
Pham
T
T
Knorz
M C
MC
Pöetzsch
D
D
D000368:Aged; D001317:Austria; D001672:Biocompatible Materials; D002387:Cataract Extraction; D005260:Female; D005858:Germany; D006801:Humans; D019654:Lens Implantation, Intraocular / Q000379:methods / Q000523:psychology; D007910:Lenses, Intraocular; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011788:Quality of Life; D012826:Silicone Elastomers; D016896:Treatment Outcome; D015348:Vision, Binocular / Q000502:physiology; D014792:Visual Acuity / Q000502:physiology
D001672:Biocompatible Materials; D012826:Silicone Elastomers