Artikel
A multi-country registry to assess the real world visual performance and patient satisfaction outcomes of a novel non-diffractive presbyopia-correcting iol
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Autoren
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Thomas Kohnen
- Frankfurt am Main
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I. Janssen
- Alcon Deutschland GmbH, Freiburg i. Br.
| Veröffentlicht: | 10. Februar 2022 |
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Gliederung
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Purpose: To report real-world visual and patient satisfaction outcomes with the ACRYSOF IQ Vivity and ACRYSOF IQ Vivity Toric Extended Vision IOL models DFT015, DFT315, DFT415, and DFT515.
Methods: An international, ambispective registry study conducted in Europe, the UK and Australia designed to report the clinical visual outcomes and patient satisfaction of patients implanted with the non-diffractive design, AcrySof IQ Vivity (DFT015) and AcrySof IQ Vivity Toric IOL (DFT315, DFT415, and DFT515) in a real-world setting and evaluated through routine clinical practice. After a minimum of 3 months follow-up per local clinical practice standards, subjects undergo visual performance assessments of visual acuity (logMAR) at distance, intermediate (66 cm) and near (40 cm) distances. Subject satisfaction via validated questionnaires are collected. This is the first interim analysis of subjects participating in this study.
Results: To date, 129 subjects with a mean age (SD) of 66.6 (10.25) years are enrolled in the study. Binocular mean (SD) (logMAR) UCDVA was 0.009 (0.088); UCIVA 0.094 (0.118) and UCNVA 0.255 (0.157). Binocular mean (SD) (logMAR) BCDVA was –0.030 (0.077); DCIVA 0.075 (0.116) and DCNVA 0.251 (0.143). At study entry, the average Manifest Refraction (MSRE) in the first eye is –0.146 (0.387) D and in the second eye –0.167 (0.321) D. Initial patient satisfaction with their sight is high, with 62.6% reporting ‘Very Satisfied’ and 31.7% ‘Fairly Satisfied’. Further, 74.8% patients report no difficulty with their sight at during everyday life and 72.6% report no difficulty to engage in activities or hobbies of their interest. There are no unanticipated AEs to date.
Conclusion: In this real-world assessment of patients bilaterally implanted with the Non-diffractive Presbyopia-Correcting ACRYSOF IQ Vivity and/or ACRYSOF IQ Vivity Toric Extended Vision IOL, we have observed very good distance, intermediate and near visual outcomes and high percentages of subjects reporting high levels of satisfaction with their vision. The study enrollment continues and additional data may be presented during the meeting.
