One Year Post-Market Clinical Study Of A Monofocal Hydrophobic Acrylic Iol With A Pre-Loaded Delivery System In A Korean Population
Published 2023 - 41st Congress of the ESCRS
Reference: PO0307 | Type: Free paper | DOI: 10.82333/x5f2-zp51
Authors: Hong Kyun Kim* 1 , Chae-Gyum Yae 1
1Department of Ophthalmology,Kyungpook National University Hospital,Daegu,Korea, Republic Of
Purpose
To report 1-year postoperative safety and performance of Clareon AutonoMe in a Korean population
Setting
A prospective, multicenter, single-arm study at 7 sites in Korea
Methods
A prospective, multicenter, single-arm trial assessing the safety and performance of Clareon AutonoMe. Participants attended 10 visits (7 post-implantation) over 1 year. The safety outcomes included adverse events (AE), device deficiencies, PCO and Nd:YAG capsulotomy rates, and IOL tilt and decentration. The performance outcomes included monocular BCDVA, glistenings, surface haze, and a surgeon delivery system preference questionnaire.
Results
125 eyes (85 patients) were implanted (40 bilateral). One eye implanted with non-study IOL was followed for safety only. 116 eyes completed the 1-year postop visit. One ocular serious AE was reported; other ocular AE: 11/126 eyes; device deficiencies: 2/126 IOL deliveries. No eyes had clinically significant PCO or Nd:YAG capsulotomy during the duration of the study. No tilt or decentration of the IOLs were observed in any eyes. 99.1% of eyes achieved monocular BCDVA of 0.2 logMAR or better. At 1 year, mean monocular BCDVA was 0.00 ± 0.10 logMAR. 100% of eyes had Grade 0 glistenings and no surface haze at 1 year. All surgeons reported “Very Easy or Easy” for incision site insertion and “very controllable or controllable” during IOL delivery.
Conclusions
This 1-year real-world study demonstrated acceptable safety and performance outcomes of the Clareon IOL and the AutonoMe Delivery System in a Korean population.