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.
Bibliographical noteFunding Information:
Medical writing assistance was provided by Catherine DeBrosse, PhD, of ICON (North Wales, PA), and was funded by Alcon.
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.
TIK is an advisory board member of and has received personal fees from Hoya Surgical Optics. TYC has nothing to disclose. MJK received grants from Alcon during the study, and has received personal and consultancy fees from Alcon unrelated to the present work. KHL was an employee of Alcon Korea Ltd. during the study. JYH received grants from Alcon Korea Ltd. during the study.
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