Multi-country clinical outcomes of a new non-diffractive extended-vision intraocular lens at six months postoperatively

Session Details

Session Title: Extended-Depth-Of-Focus IOLs I

Session Date/Time: Sunday 15/09/2019 | 14:00-16:00

Paper Time: 14:12

Venue: Free Paper Forum: Podium 1

First Author: : F.Poyales SPAIN

Co Author(s): :    A. Mearza   D. Varma   C. Balachandran   J. Lemp-Hull                    

Abstract Details

Purpose:

To evaluate clinical outcomes of binocular implantation of a new non-diffractive extended vision intraocular lens (Alcon DFT015)

Setting:

Multicenter, multicountry clinical trial sponsored by Alcon

Methods:

This study bilaterally implanted 154 and 119 subjects with the DFT015 and SN60WF (monofocal control), respectively at 19 sites in Canada, UK, Spain and Australia. At 6 months post-op, monocular primary and secondary endpoints of best corrected distance (CDVA, 4m), distance corrected intermediate (DCIVA, 66cm) and distance corrected near visual acuity (DCNVA, 40cm) and defocus curve were assessed. Binocular uncorrected distance (UDVA), intermediate (UIVA), and near visual acuity (UNVA) and defocus curve were also assessed along with quality of vision (QoV Questionnaire, McAlinden) and overall safety.

Results:

DFT015 demonstrated non-inferior monocular CDVA, superior DCIVA, superior DCNVA and >0.5D extended range of vision at 0.2 logMAR compared to SN60WF. DFT015 provided 20/20 binocular UDVA; and >half a line improvement in UIVA and > 1 line improvement in UNVA compared to SN60WF. For both groups, the majority of subjects were not at all bothered by starbursts, halos, and glare; and reported rates of severe visual disturbances were low (<4%). Rates of adverse events and of clinically non significant or significant PCO and YAG were low and similar between groups.

Conclusions:

In comparison with an aspheric monofocal, this non-diffractive extended vision IOL improves near and intermediate vision without affecting distance vision while maintaining a monofocal-like visual disturbance profile.

Financial Disclosure:

is employed by a for profit company with an interest in the subject of the presentation, 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, receives consulting fees, retainer, or contract payments from a competing company, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented