Visual disturbance profile of a non-diffractive extended vision intraocular lens from two pivotal trials

Session Details

Session Title: Presented Poster Session: Enlarged Depth of Focus vs Multifocal IOLs

Venue: Poster Village: Pod 1

First Author: : C.McCabe USA

Co Author(s): :    J. Berdahl   J. Lemp-Hull   F. Poyales   C. Balachandran              

Abstract Details

Purpose:

To evaluate and compare the rates of visual disturbances (VDs) with a novel non-diffractive extended vision intraocular lens (Alcon DFT015) from two large pivotal trials

Setting:

Multicenter multicountry clinical trials sponsored by Alcon

Methods:

Eleven U.S. surgeons (Study 1) and 19 surgeons in the UK, Spain, Australia, and Canada (Study 2) bilaterally implanted 106 and 154 subjects with DFT015 and 113 and 119 subjects with a SN60WF in 2 prospective, randomized, subject and assessor masked trials.  At pre-op, 1mo post-op and 6mo post-op, study 1 subjects reported frequency, severity and level of bother with starbursts, halos, glare, hazy vision, double vision, blurry vision and negative dysphotopsia on the Questionnaire for Visual Disturbances (QUVID) developed by Alcon. At 6mo post-op, Study 2 subjects reported halos, glare and starbursts on the QoV questionniare (McAlinden).

Results:

In both trials, DFT015 extended vision >0.5 D over SN60WF at 0.2 logMAR.  In Study 1 at 6mo, there were no significant differences between DFT015 and SN60WF in rates of six of the seven VDs; however, significantly more subjects reported never experiencing the visual disturbance of blurred vision for DFT015 compared to SN60WF. In both trials, the majority of subjects in both groups were not at all bothered by starbursts, halos, and glare, with <5% difference between groups, except on the Study 2 where >5% more DFT015 subjects were not at all bothered with starbursts and glare compared to SN60WF.

Conclusions:

Two randomized, aspheric monofocal controlled, double masked, pivotal trials found that bilateral implantation of this non-diffractive extended vision IOL provided subjects with an extended range of vision from distance to near, while maintaining a visual disturbance profile similar to a monofocal.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... travel has been funded, fully or partially, by a competing company, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a competing company, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a competing company