Clinical Ophthalmology (Nov 2023)

Clinical Evaluation of a Hydrophobic Intraocular Lens Using a Preloaded Automated Injector in a Korean Population

  • Kim HK,
  • Seo KY,
  • Yoon KC,
  • Choi CY,
  • Chung TY,
  • Hyon JY,
  • Rendon A,
  • Kim HS

Journal volume & issue
Vol. Volume 17
pp. 3353 – 3363

Abstract

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Hong Kyun Kim,1 Kyoung Yul Seo,2 Kyung Chul Yoon,3 Chul Young Choi,4 Tae-Young Chung,5 Joon Young Hyon,6 Alexis Rendon,7 Hyun Seung Kim8 1Department of Ophthalmology, School of Medicine, Kyungpook National University, Daegu, Republic of Korea; 2Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine; Cornea Dystrophy Research Institute, Seoul, Republic of Korea; 3Department of Ophthalmology, Chonnam National University Medical School and Hospital, Gwangju, Republic of Korea; 4Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 5Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea; 6Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea; 7Alcon Vision LLC, Fort Worth, TX, USA; 8Department of Ophthalmology and Visual Science, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of KoreaCorrespondence: Hyun Seung Kim, Department of Ophthalmology and Visual Science, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea, Email [email protected]: This study assessed post-market clinical outcomes of the Clareon monofocal intraocular lens (IOL) preloaded in the AutonoMe Delivery System in a real-world setting of Korean patients.Methods: This prospective, multicenter, single-arm study in Korea was conducted from July 2020 to December 2021. Patients were ≥ 20 years old with unilateral or bilateral cataracts who received Clareon IOLs (CNA0T0) preloaded in an automated injector system. Best corrected distance visual acuity (BCDVA) and uncorrected distance visual acuity (UCDVA) were evaluated under photopic conditions. Surgeon delivery system preference was assessed using a survey questionnaire. Glistenings, surface haze, adverse events, posterior capsule opacification (PCO), and Nd:YAG capsulotomy rates were also assessed during the 12-month postoperative follow-up.Results: Mean ± SD monocular BCDVA was 0.02 ± 0.11 and 0.00 ± 0.10 logMAR at 1 month and 12 months, respectively. BCDVA of 0.2 logMAR or better was achieved by 94.4% and 99.1% of eyes at 1 month and 12 months after implantation, respectively. Mean monocular UCDVA was 0.11 ± 0.14 and 0.07 ± 0.13 logMAR at 1 month and 12 months, respectively. UCDVA of 0.3 logMAR or better was achieved by 97.4% of eyes at 12 months after implantation. Preparation of the automated injector system was rated as “very easy” or “easy” and CNA0T0 IOL delivery was rated as “very controllable” or “controllable” by all surgeons. Only grade 0 glistenings and no surface haze were observed during the 12-month follow-up. No clinically significant PCO or Nd:YAG capsulotomy were reported throughout the study; clinically nonsignificant PCO was reported in 23% of eyes.Conclusion: This 12-month real-world study of the CNA0T0 IOL and the automated injector system demonstrated excellent visual outcomes and high surgeon satisfaction.Keywords: visual acuity, intraocular lens delivery, glistenings, surface haze, surgeon’s preference questionnaire

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