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Visual outcomes and patient satisfaction after implantation of a new non-diffractive presbyopia-correcting intraocular lens

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First Author: C.McCabe USA

Co Author(s):    A. Martinez                    

Abstract Details

Purpose:

Extended-depth-of-focus intraocular lenses (IOLs) are intended to address the vision quality issues of both monofocal and multifocal IOLs by improving range of vision while maintaining high-quality distance vision and a monofocal-like visual disturbance profile. This study evaluated the functional vision outcomes and safety profile of a new non-diffractive presbyopia-correcting intraocular lens (IOL) AcrySof® IQ Vivity (model DFT015) versus an aspheric monofocal IOL (model SN60WF).

Setting:

Eleven sites in the USA.

Methods:

This prospective, multicentre, non-randomized, parallel-group, confirmatory trial enrolled cataract patients, who were bilaterally implanted with DFT015 and SN60WF (106 and 113 patients, respectively). Co-primary and secondary effectiveness objectives for DFT015 versus SN60WF at Month 6 were to demonstrate non-inferiority in mean photopic monocular best-corrected distance visual acuity (BCDVA; 4m), superiority in mean photopic monocular distance-corrected intermediate VA (DCIVA; 66cm) and distance-corrected near VA (DCNVA, 40cm), and a greater range of defocus at 0.2 logMAR in the first operative eye. Cumulative rates of secondary surgical interventions and patient-reported visual disturbances (validated Questionnaire for Visual Disturbance, QUVID) were also analysed.

Results:

Superiority of DFT015 to SN60WF in mean photopic monocular DCIVA (difference of -0.164 logMAR; p<0.001) and distance-corrected near visual acuity (difference of -0.156 logMAR; p<0.001), and non-inferiority in mean photopic monocular BCDVA (95% upper confidence limit of the difference was <0.1 logMAR margin), were demonstrated. The monocular defocus curve for DFT015 showed a greater negative range of defocus (difference of 0.54 D at 0.2 logMAR), compared with SN60WF. Most patients in both groups reported never being bothered by the surveyed visual disturbances.

Conclusions:

This large study demonstrates that the non-diffractive presbyopia-correcting IOL DFT015 provides improved distance-corrected intermediate and near vision, increased depth of focus, versus the aspheric monofocal IOL SN60WF, while maintaining a similar distance vision and 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 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, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented