Clinical Outcomes and Quality of Vision Associated with Bilateral Implantation of a Wavefront Shaping Presbyopia Correcting Intraocular Lens

Abstract

Purpose

To provide normative visual acuity and quality of vision data related to bilateral implantation of a wavefront shaping presbyopia correcting intraocular lens (IOL).

Patients and Methods

This was a non-interventional research study of the refraction, visual acuity (VA) and quality of vision achieved after bilateral implantation of a wavefront shaping presbyopia correcting intraocular lens between 3 months and 12 months post-surgery. The manifest refraction, and uncorrected and distance corrected VA at near, intermediate and distance (40 cm, 50 cm, 66cm, 4 m) were tested. Binocular mesopic VA at 4m and uncorrected photopic low contrast (25%) VA at 4 m were also tested, the latter with and without a glare source. A patient reported outcome questionnaire was administered. Defocus curve testing with and without simulated myopia in the non-dominant eye was also tested (reported elsewhere).

Results

Forty subjects completed the study. There was no statistically significant difference between the uncorrected and distance corrected VA at any distance. Mean logMAR binocular VAs were (−0.07 ± 0.07) at 4 m, (0.00 ± 0.07) at 66 cm and (0.07 ± 0.11) at 40 cm. Uncorrected photopic low contrast VA was statistically significantly better without glare (0.09 ± 0.10) compared to with glare (0.44 ± 0.21, p < 0.01). Reported glare, halos and starbursts were “not at all” Or “a little” bothersome for more than 95% of subjects. Hazy vision and blurred vision were reported most often.

Conclusion

The Vivity IOL provided patients with good distance and intermediate vision, and functional near vision with low reported bother from glare, halos, or starbursts.

Graphical abstract

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Keywords:

• non-diffractive
• extended depth of focus
• extended vision
• cataract
• presbyopia
• quality of vision
• wavefront shaping

Acknowledgments

Steffen Østenstad, MSc, of IFocus Øyeklinikk AS assisted with diagnostic testing and data collection/checking. This work was supported by as an investigator-initiated study grant funded by Alcon (IIT#61478839). Preliminary results from this study were presented at the 2021 American Society of Cataract and Refractive Surgery conference (Las Vegas, USA, July 23–27, 2021) and the 2021 European Society of Cataract and Refractive Surgery (Amsterdam, NL, October 8–11, 2021) in conference lectures.

Disclosure

Drs. Gundersen and Potvin are consultants to Alcon. Dr Potvin reports personal fees from Alcon and Carl Zeiss Meditec, outside the submitted work. The authors report no other conflicts of interest in this work.