Randomized trial of multifocal intraocular lenses versus monovision after bilateral cataract surgery

Abstract

Objective: To compare spectacle independence in patients randomized to receive bilateral multifocal intraocular lenses (IOLs) or monofocal IOLs with the powers adjusted to produce monovision.

Design: Randomized, multicenter clinical trial.

Participants: A total of 212 patients with bilateral, visually significant cataract.

Methods: Before bilateral sequential cataract surgery, patients were randomized (allocation ratio 1:1) to receive bilateral Tecnis ZM900 diffractive multifocal lenses (Abbott Medical Optics, Santa Ana, CA) or Akreos AO monofocal lenses (Bausch & Lomb, Rochester, NY) with the powers adjusted to target -1.25 diopters (D) monovision. Outcomes were assessed 4 months after the second eye underwent operation.

Main outcome measures: The primary outcome was spectacle independence. Secondary outcomes included questionnaires (VF-11R, dysphotopsia symptoms, and satisfaction) and visual function measures (near, intermediate, and distance logarithm of minimum angle of resolution [logMAR] visual acuity, stereoacuity, contrast sensitivity, and forward light scatter).

Results: A total of 212 patients were randomized, and 187 patients (88%) returned for assessment 4 months after surgery. Uniocular distance refractions in the monovision arm showed a mean spherical equivalent of +0.075 D in the distance eye and -0.923 in the near eye. In the multifocal arm, the mean distance spherical equivalents were -0.279 D and -0.174 D in the right and left eyes, respectively. A total of 24 of 93 patients (25.8%) in the monovision arm and 67 of 94 patients (71.3%) in the multifocal arm reported never wearing glasses (P<0.001, Fisher exact test). The adjusted odds ratio of being spectacle free was 7.51 (95% confidence interval, 3.89-14.47). Binocular uncorrected acuities did not differ significantly for distance (0.058 logMAR for monovision vs. 0.076 for multifocal, P = 0.3774) but were significantly worse in the multifocal arm for intermediate acuity (0.149 vs. 0.221, P = 0.0001) and in the monovision arm for near acuity (0.013 vs. -0.025, P = 0.037). In the first postoperative year, 6 patients (5.7%) in the multifocal arm underwent IOL exchange (4 had a bilateral and 2 had a unilateral exchange). No patients in the monovision arm underwent IOL exchange.

Conclusions: Patients randomized to bilateral implantation with the diffractive multifocal Tecnis ZM900 were more likely to report being spectacle independent but also more likely to undergo IOL exchange than those randomized to receive monofocal implants (Akreos AO) with the powers adjusted to give low monovision.