Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial.

ABSTRACT:

Purpose

To compare the effectiveness and safety of the TECNIS Symfony intraocular lens (IOL; ZXR00) with the TECNIS 1-piece monofocal IOL (ZCB00).

Setting

15 sites in the United States.

Design

Prospective, randomized, patient-masked/evaluator-masked clinical trial.

Methods

Randomized participants received either the ZXR00 or ZCB00 IOL bilaterally. The 6-month postoperative outcomes included monocular and binocular distance, intermediate, and near visual acuity (VA), spherical equivalent refraction and refractive cylinder, spectacle wear, and visual symptoms.

Results

Overall, 299 patients were implanted with a study IOL (ZXR00 IOL, n = 148; ZCB00 IOL control, n = 151). At the 6-month follow-up, mean binocular uncorrected distance VA was comparable between

SUBMITTER: Chang DH 

PROVIDER: S-EPMC8865208 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature