Background: To investigate the 3-month postoperative performance and safety after implantation of a trifocal intraocular lens (IOL) in a Korean population. Methods: This was a clinical, prospective, multicenter, single-arm study. Forty-four subjects (88 eyes) with bilateral cataract with expected postoperative corneal astigmatism of < 1.00 diopter (D) and no ocular disease or eye condition underwent bilateral implantation of the AcrySof IQ® PanOptix IOL (TFNT00). Postoperative examination at 3 months included binocular defocus curve; binocular best corrected distance visual acuity (BCDVA); monocular/binocular uncorrected VA (UCVA) at distance (4 m), intermediate (60 cm), and near (40 cm); contrast sensitivity under photopic conditions with/without glare; and subjective outcomes, including satisfaction and spectacle independence. Results: Binocular defocus curve at 3 months after bilateral implantation showed VA of 0.1 logMAR or better from + 0.5 D through - 2.5 D. Binocular BCDVA mean ± SD at 4 m was - 0.05 ± 0.07 logMAR. Binocular and monocular UCVA was 0.03 ± 0.1 and 0.08 ± 0.12 logMAR (4 m), - 0.00 ± 0.11 and 0.05 ± 0.13 logMAR (60 cm), and 0.03 ± 0.12 and 0.09 ± 0.13 logMAR (40 cm), respectively. Contrast sensitivity with glare was 1.67 ± 0.13, 1.91 ± 0.17, 1.54 ± 0.21, and 1.14 ± 0.20 log units at 3, 6, 12, and 18 cycles/degree, respectively. At near and intermediate distances, 84 and 77% of subjects reported good/excellent satisfaction, and 84 and 91% of subjects reported spectacle independence, respectively. Conclusions: In a Korean population, visual performance of the trifocal TFNT00 IOL 3 months postoperatively was < 0.1 logMAR for binocular UCVA at all distances, with high subject satisfaction and spectacle independence. Trial registration: www.ClinicalTrials.gov (NCT03268746). Registered August 31, 2017.
|Publication status||Published - 2020 Jul 15|
Bibliographical noteFunding Information:
This study was funded by Alcon Research LLC, Fort Worth, TX, USA, and Alcon Korea Ltd., Seoul, South Korea. The sponsor participated in study design; data management, analysis, and interpretation; and funding for the manuscript preparation.
Medical writing assistance was provided by Catherine DeBrosse, PhD, of ICON (North Wales, PA), and was funded by Alcon.
© 2020 The Author(s).
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