Volume 35, Issue 12 , Pages 2054-2061, December 2009
Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power:
Randomized multicenter clinical study
Purpose
To evaluate functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses (IOLs) with a +3.0 or +4.0 diopter (D) addition (add) power.
Setting
Twelve study centers in the United States.
Methods
This randomized patient-masked parallel-group 6-month follow-up study comprised patients having bilateral cataract extraction with implantation of an AcrySof IQ ReSTOR SN6AD3 IOL with a +4.0 D add power (+4.0 D group) or an AcrySof IQ ReSTOR SN6AD1 IOL with a +3.0 D add power (+3.0 D group) (both IOLs, Alcon, Inc.). Visual acuity, defocus testing, patient-reported outcomes, and safety measures were assessed.
Results
Of the 279 patients, 141 were in the +3.0 D group and 138 were in the +4.0 D group. Binocular distance-corrected intermediate visual acuity was statistically significantly better in the +3.0 D group than in the +4.0 D group (P<.0001); there was no difference in binocular near or distance visual acuity. There were no statistically significant differences in visual disturbances between the 2 groups. Patients in both groups reported excellent overall spectacle independence, near visual function, and satisfaction with the IOLs.
Conclusions
Intermediate vision at a mean reading distance of approximately 40 cm was better with the aspheric IOL with a +3.0 D add than with the aspheric IOL with a +4.0 D add, as shown by the near peak in the mean binocular defocus curve; near and distance acuity were similar between the 2 IOLs. Patients reported excellent overall quality of vision, spectacle independence, and satisfaction.
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Dr. Maxwell is a medical monitor for and Drs. Cionni, Lehmann, and Modi are consultants to Alcon Laboratories, Inc., Fort Worth, Texas, USA.
Sponsored by Alcon Laboratories, Inc.
Jennifer Klem, PhD, provided medical writing assistance.
PII: S0886-3350(09)00857-8
doi:10.1016/j.jcrs.2009.06.041
© 2009 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.
Volume 35, Issue 12 , Pages 2054-2061, December 2009
