Clinical Outcomes With A Wavefront Shaping Extended Depth Of Focus Iol – A Pooled Analysis Of Prospective Clinical Investigations

To report the visual outcomes of subjects from different regions implanted with a wavefront shaping extended depth of focus intraocular lens (EDF IOL), the AcrySof IQ Vivity IOL Model (DFT015).

Three prospective, controlled clinical trials conducted in Australia, Europe, and North America.

This paper presents the results of a pooled analysis of 6 months post-operative MRSE, uncorrected, best-corrected visual acuity at distance, intermediate (66cm) and near (40cm), binocular depth of focus and patient reported visual disturbances from subjects binocularly implanted with the DFT015 IOL or the SN60WF monofocal IOL targeting emmetropia. Our report includes a large sample of subjects sourced from 3 prospective, controlled clinical trials conducted in Australia, Europe, and North America using comparable clinical methods and validated questionnaires.

Data was pooled for a total of 326 subjects implanted with DFT015 and 233 subjects implanted with the monofocal IOL. The mean binocular defocus curve at 3-6 months post-op indicated a visual acuity of ≤ 0.2 logMAR from +1.0D to -2.00D.  Binocular uncorrected distance, intermediate (66cm) and near (40cm) logMAR VAs were 0.024 (0.120), 0.061 (0.102), and 0.220 (0.139) for DFT015 and -0.019 (0.110), 0.125 (0.145), 0.342 (0.170) for SN60WF respectively. Similar, high rates of DFT015 subjects (>73%) and SN60WF subjects (>68%) reported they were not at all bothered by starbursts, halos, or glare.

Data from a large pool of bilaterally implanted subjects from multiple regions, indicates Acrysof IQ Vivity provides 20/20 distance vision, >20/25 intermediate vision and 20/32 near vision while maintaining a visual disturbance profile similar to a monofocal IOL.