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

Hong Kyun Kim; Kyoung Yul Seo; Kyung Chul Yoon; Chul Young Choi; Tae-Young Chung; Joon Young Hyon; Alexis Rendon; Hyun Seung Kim

doi:10.2147/OPTH.S421864

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

Clin Ophthalmol. 2023 Nov 3:17:3353-3363. doi: 10.2147/OPTH.S421864. eCollection 2023.

Authors

Hong Kyun Kim¹, Kyoung Yul Seo², Kyung Chul Yoon³, Chul Young Choi⁴, Tae-Young Chung⁵, Joon Young Hyon⁶, Alexis Rendon⁷, Hyun Seung Kim⁸

Affiliations

¹ Department of Ophthalmology, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.
² Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine; Cornea Dystrophy Research Institute, Seoul, Republic of Korea.
³ Department of Ophthalmology, Chonnam National University Medical School and Hospital, Gwangju, Republic of Korea.
⁴ Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
⁵ Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
⁶ Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.
⁷ Alcon Vision LLC, Fort Worth, TX, USA.
⁸ Department of Ophthalmology and Visual Science, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

Abstract

Purpose: 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: glistenings; intraocular lens delivery; surface haze; surgeon’s preference questionnaire; visual acuity.

Grants and funding

This study was funded by Alcon Research LLC. Alcon assisted with the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.