Comparison Of Visual And Refractive Outcomes After Implantation Of The Toric And Non-Toric Version Of A Purely Refractive Edof Iol

To compare real-world visual and refractive outcomes of the toric and non-toric model of the same purely refractive Extended Depth of Focus (EDOF) PCIOL TECNIS PureSee.

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

This is a multicentre, observational, single-arm, single-visit study with three months follow up. postoperatively 64 subjects (66.3 ± 8.69 years) bilaterally implanted with TECNIS PureSee Toric IOLs and 179 subjects (64.2 ± 9.37 years) bilaterally implanted with the non-toric version of the same IOL were evaluated. Monocular and binocular uncorrected (UCVA) and corrected (CDVA) distance visual acuity; binocular uncorrected intermediate (UIVA at 66 cm) and near (UNVA at 40 cm) visual acuity; manifest refraction spherical equivalent (MRSE) and cylinder; and patient satisfaction without glasses were assessed. 

Postoperatively, the results for the toric /non-toric respectively were, for MRSE s -0.11 ± 0.39 D / 0.01 ± 0.4 D,  manifest cylinder  -0.34 ± 0.34 / -0.30 ± 0.32D  and mean monocular distance logMAR UDVA and CDVA ,0.04 ± 0.13 / 0.04 ± 0.10 and -0.04 ± 0.08 / -0.02 ± 0.07. Binocularly, 92% / 87% of patients  achieved UDVA of ≤0.0 logMAR (mean -0.04 ± 0.08 / -0.01 ± 0.09), and 98% / 97% achieved CDVA of ≤0.0 LogMAR (mean -0.07 ± 0.07 / -0.05 ± 0.07); UIVA was 0.13 ± 0.12 / 0.12 ± 0.11, with 84% /89% achieving UIVA of ≤0.2 LogMAR, and mean UNVA was 0.29 ± 0.12 / 0.24 ± 0.18 (73% in each group achieving UNVA of ≤0.3 LogMAR). 94% / 93% were “mostly” or “completely” satisfied with overall vision without glasses.

This real‑world evidence demonstrates comparable refractive outcomes, visual performance, and satisfaction with overall vision without glasses  in patients implanted with either the toric or non‑toric models of the TECNIS PureSee EDOF IOL.