Patient Reported Outcomes In Patients Bilaterally Implanted With The Toric Or Non-Toric Model Of A Purely Refractive Edof Iol

To compare patient reported outcomes in patients implanted with a toric or a non- toric version of the same   purely refractive Extended Depth of Focus (EDOF), TECNIS PureSee IOL.

Data from 18 investigational sites in Europe and Asia-Pacific.

This is a multicentre, observational, single-arm study with a single-visit at 3 months post operatively. 64 subjects were bilaterally implanted with toric TECNIS PureSee IOLs and 179 were bilaterally implanted with the non-toric version of the same IOL, mean age was 66.3 ± 8.69 (toric) and 64.2 ± 9.37 (non-toric) years. Manifest refraction spherical equivalent (MRSE), binocular uncorrected visual acuity (VA) results for distance (UDVA) and intermediate at 66 cm (UIVA), rates of photic phenomena (glare, halo and starburst), spectacle independence and patient satisfaction using validated questionnaires are reported.

Postoperatively, MRSE was -0.11 ± 0.39 D and 0.01 ± 0.4 D in the toric and non-toric groups, respectively.  Mean binocular UDVA (toric / non-toric) was -0.04 ± 0.08 / -0.01 ± 0.09 logMAR. Binocular UIVA were 0.13 ± 0.12 / 0.12 ± 0.11 LogMAR. 88% / 91% of subjects reported being “not at all” or only “a little” bothered by glare, 86% / 93% by halos, and 88% / 92% by starbursts, respectively. Use of glasses “none” or “a little” of the time was reported by 92% / 97% for far distance and 90% / 95% for intermediate distance. 94% of toric and 93% non-toric subjects were completely or mostly satisfied with their overall vision at all distances without correction.

This real-world evidence shows high rates of spectacle independence and satisfaction without glasses for far and intermediate distances for patients implanted with the toric and non-toric models of the same purely refractive EDOF IOL. Comparable binocular visual outcomes for distance and intermediate were also found. A high percentage of patients were little or not at all bothered by photic phenomena like glare, halo and starburst regardless of the implantation of a toric or non toric version.  The toric model of TECNIS PureSee EDOF IOL offers comparable visual quality and a level of spectacle independence that are on par with those achieved by the non-toric model.