Real-World Visual Performance Of A Novel Presbyopia-Correcting Iol With A Wavefront-Shaping Design: Results For Subjects Implanted In Belgium

To report real world clinical visual performance of a sub-group of subjects bilaterally implanted with AcrySof IQ Vivity™ extended vision IOL (models DFT015 and DFTX15-Toric) in Belgium.

Multicenter, ambispective registry study conducted in Europe, the UK, Australia and New Zealand evaluating the performance of bilaterally implanted AcrySof IQ Vivity and AcrySof IQ Vivity Toric IOL in a real world setting through routine clinical practice.

After a minimum of 3 months of follow-up, subjects underwent visual performance analysis of binocular uncorrected visual acuities at distance (UCDVA), intermediate (UCIVA, 66 cm) and near (UCNVA, 40 cm). Patient satisfaction, spectacle independence and visual disturbances were also assessed. This is the second interim analysis of subjects participating in this study in Belgium. The study is currently ongoing in Australia, New Zealand, Europe and the UK.

In total, 47 subjects have been implanted with IOL models DFT015 or DFTX15-Toric among three different sites in Belgium. Binocular mean (standard deviation) logMAR UCDVA was -0.027 (0.084), UCIVA 0.093 (0.098) and UCNVA 0.325 (0.149). This Belgium sub-population showed clinically consistent outcomes as the overall study cohort (N=757). More than 86% of the subjects never needed to wear spectacles at distance and intermediate, and 97.7% of subjects were satisfied with their sight. In addition, 97.7%, 95.5% and 97.7% of subjects were not at all bothered by halos, starbursts or glare, respectively.

In this assessment of subjects bilaterally implanted with DFT015/DFTX15-Toric IOLs in Belgium, we have observed good distance, intermediate and functional near vision. Subjects in Belgium also reported high levels of satisfaction with their vision, good levels of spectacle independence and low levels of visual disturbances.