Elsevier

Ophthalmology

Volume 120, Issue 12, December 2013, Pages 2449-2455.e1
Ophthalmology

Original article
Randomized Trial of Multifocal Intraocular Lenses versus Monovision after Bilateral Cataract Surgery

https://doi.org/10.1016/j.ophtha.2013.07.048Get rights and content

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.

Financial Disclosure(s)

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Section snippets

Study Design

The study was conducted at 2 hospitals: Moorfields Eye Hospital, London, United Kingdom, and King's College Hospital, London, United Kingdom. The protocol was approved by the Collaborative Research Ethics Committee. Informed written consent was obtained from all patients according to the tenets of the Declaration of Helsinki. The study was a randomized controlled trial and has been registered at www.controlled-trials.com/ISRCTN37400841 (accessed May 12, 2013).

Enrollment of Participants, Data Collection, and Follow-up

Patients with bilateral cataract

Results

Between April 28, 2007, and August 25, 2010, 212 patients were enrolled. One patient became unwell immediately after randomization and never underwent surgery as part of the trial. The 2 arms of the study were similar in age (68.7±12.0 years for monovision vs. 67.0±11.2 for multifocal) and sex (female 57.5% for monovision vs. female 55.7% for multifocal).

The flow of patients through the trial is shown in Figure 1. Six patients had IOLs implanted that they were not randomized to receive. Five

Discussion

This study shows that patients undergoing bilateral cataract surgery randomized to bilateral implantation with the Tecnis ZM900 multifocal IOL achieve higher spectacle independence than those randomized to receive the Akreos AO IOL with lens power selection adjusted to achieve low monovision. Patient satisfaction was high in both arms, but dysphotopsia scores were higher in patients randomized to multifocal IOL implantation. Glare in particular was reported more frequently by patients receiving

References (33)

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Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Funded by an unrestricted grant from Abbott Medical Optics and Bausch & Lomb. The funding organizations had no role in the design or conduct of this research. This work was supported in part by the UK National Institute for Health Research Biomedical Research Centre in Ophthalmology at Moorfields Eye Hospital and UCL Institute of Ophthalmology.

A full listing of the Moorfields IOL Study Group is available at http://aaojournal.org.

A full listing of the Moorfields IOL Study Group is available at http://aaojournal.org.

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