Repeatability and reproducibility of anterior lens zonule length measurement using ArcScan insight 100 very high-frequency ultrasound

• Published in: Expert review of medical devices Vol. 20; no. 8; p. 703
• Main Authors: Zhu, Zehui, Zou, Han, Li, Hongzhe, Wu, Xueer, Wang, Yiyi, Li, Zhangliang, Zhao, Yune
• Format: Journal Article
• Language: English
• Published: England 03.08.2023
• Subjects: Adult; Eye; Female; Humans; Lens, Crystalline - diagnostic imaging; Male; Reproducibility of Results; Ultrasonography; Young Adult; repeatability; Insight-100; very high-frequency ultrasound; lens zonule; reproducibility
• ISSN: 1745-2422
• DOI: 10.1080/17434440.2023.2223967

This study aimed to evaluate the intra-examiner repeatability and inter-examiner reproducibility in lens zonular length measurements using very high-frequency digital ultrasound (Insight 100). Two examiners performed ultrasound imaging independently in each subject. The length of temporal and nasal zonules were then measured with a built-in software. Coefficient of variations (CVs) of the three repeated measurements were used to determine intra-examiner variances. Inter-examiner reproducibility was evaluated using intraclass correlation coefficients (ICCs) and the Bland-Altman method. 40 eyes of 40 subjects (14male and 26female; mean age 23.9 ± 2.4 years) were included in the study. The CVs for intra-examiner measurement were 2.74% temporally and 4.32% nasally for Examiner 1, and were 1.96% temporally and 1.75% nasally for Examiner 2. For inter-examiner reproducibility, all ICCs were above 0.9. However, there were significant differences between the two examiners in temporal zonular length measurements (  = 0.001), and the differences mainly came from measuring the zonular length manually (  = 0.001) rather than recording images (  = 0.480). No significant differences were found between two measurements by the same examiner after one month (all  > 0.05, all ICCs > 0.8). The Insight 100 device can be used to measure the length of anterior lens zonule with relatively good repeatability and reproducibility. www.clinicaltrials.gov identifier is NCT05657951.