Assessing Performance And Safety Of Aspheric Monofocal Toric Iol Including Stability And Functional Intermediate Visual Acuity Outcomes

To assess and report the distance and intermediate visual outcomes, rotational stability, and adverse events of patients implanted with a Clareon Toric aspheric intraocular lens (IOL) preloaded in the AutonoMe delivery system (CNA0T2-T6) up to 1m postoperative.

Single-surgeon cohort. Adelaide Australia

This is a retrospective, single-cohort, real-world evidence chart review of adult eyes (18 years and over). Surgical charts from Jan 2021 to Oct 2023 were reviewed for patients who previously received a CNA0T2-T6 IOL during uneventful cataract surgery, and were targeted for emmetropia/first minus. Postoperative assessments included monocular best-corrected distance visual acuity (BCDVA), uncorrected and distance-corrected intermediate visual acuity (UCIVA and DCIVA) and residual astigmatism up to 1m. Absolute IOL rotation was measured from the axis position at the end of surgery (EOS) up to 1m. All identified adverse events (AEs) and device deficiencies were reported. Ad hoc analysis was also performed on those receiving CNA0T3-T6 IOLs.

193 eyes of 121 subjects were screened, 161 eyes of 107 subjects (aged 74 +/- 7.57y) were included. For the full cohort (who received T2-T6 IOLs, n=161 eyes), BCDVA improved from 0.23 +/- 0.23 logMAR pre-implantation to -0.01 +/- 0.07 logMAR at 1m. UCIVA was 0.22 +/- 0.14, DCIVA was 0.24 +/- 0.12 logMAR and absolute IOL rotation was 1.02 +/- 1.21º at 1m. Residual astigmatism was very low (<0.01D) and consistently low across T2-T6. The T3-T6 analysis (n=64 eyes) found BCDVA of -0.01 +/- 0.07 logMAR, UCIVA of 0.20 +/- 0.14 logMAR, DCIVA of 0.23 +/- 0.13 logMAR and absolute rotation of 1.08 +/- 1.26º at 1m. For all eyes, 1 serious ocular AE (CME) was identified, no serious AEs or AutonoMe deficiencies were reported and no PCO was observed.

The Clareon Aspheric Monofocal Toric IOL showed excellent improvement in distance visual acuity and treatment of astigmatism, with functional IVA consistent with the Clareon non-toric IOL. IOL rotation and adverse events were minimal. Based on ISO guidelines, this IOL is effective and safe to implant following cataract extraction.