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Dataset Information

Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL.


ABSTRACT:

Purpose

To evaluate the effectiveness and safety of a new presbyopia-correcting intraocular lens (IOL) with a nondiffractive design, DFT015, compared with an aspheric monofocal IOL, SN60WF.

Setting

19 investigational sites in 4 countries: Australia, Canada, Spain, and the United Kingdom.

Design

Prospective, randomized, parallel-group, controlled, assessor- and patient-masked clinical study.

Methods

Participants aged ≥22 years with bilateral cataracts were randomized to DFT015 or SN60WF in a 5:4 ratio and masked until final postoperative follow-up at month 6. The primary effectiveness objective was superiority of DFT015 over SN60WF in mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) at month 3. Secondary effectiveness objectives incl

SUBMITTER: Bala C 

PROVIDER: S-EPMC8845530 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature