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

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:

• visual acuity
• intraocular lens delivery
• glistenings
• surface haze
• surgeon’s preference questionnaire

Abbreviations

AE, adverse event; BCDVA, best corrected distance visual acuity; IOL, intraocular lens; Nd:YAG, neodymium-doped yttrium aluminium garnet; PCO, posterior capsule opacification; SSNG, sub-surface nano-glistenings; UCDVA, uncorrected distance visual acuity.

Data Sharing Statement

The data used to support the primary findings of this study are available upon reasonable request from the study sponsor, Alcon Research LLC.

Acknowledgments

Medical writing assistance was provided by Lisa Denny, PhD, of ICON plc (Blue Bell, PA), and was funded by Alcon.

Author Contributions

All authors made a significant contribution to the work reported, whether that was in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; agreed on the journal to which the article has been submitted; and agreed to be accountable for all aspects of the work.

Disclosure

Hong Kyun Kim, Kyoung Yul Seo, Joon Young Hyon, and Hyun Seung Kim were consultants to Alcon. Kyung Chul Yoon and Chul Young Choi were consultants and clinical investigators for Alcon. Tae-Young Chung was a consultant/speaker and a clinical investigator for Alcon. Alexis Rendon is an employee of Alcon Research LLC. The authors report no other conflicts of interest in this work.

Additional information

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.