Journal of Cataract & Refractive Surgery
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

From private practices, Fresno, California (Maxwell), Cincinnati, Ohio (Cionni), Nacogdoches, Texas (Lehmann), and Poughkeepsie, New York (Modi), USA

Received 6 March 2009; received in revised form 4 June 2009; accepted 5 June 2009.

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

Journal of Cataract & Refractive Surgery
Volume 35, Issue 12 , Pages 2054-2061, December 2009