Clinical Validation of a New Optical Biometer for Myopia Control in a Healthy Pediatric Population

Area of Science:

• Ophthalmology
• Biomedical Engineering
• Pediatric Optometry

Background:

• Accurate biometric measurements are crucial for pediatric eye care and myopia management.
• The Myah device is a new tool for ocular biometry, requiring validation in pediatric populations.
• Assessing device repeatability and agreement with established systems is essential for clinical adoption.

Purpose of the Study:

• To evaluate the clinical validation of the Myah device in children.
• To assess the repeatability of corneal radius (K1, K2), white-to-white distance (WTW), and axial length (AL) measurements using the Myah device.
• To analyze the agreement between the Myah device and the Myopia Master system for these biometric parameters.

Main Methods:

• Fifty-one children (51 eyes) underwent repeated measurements with the Myah device.
• Parameters measured included flat (K1) and steep (K2) corneal radius, white-to-white (WTW) distance, and axial length (AL).
• Agreement analysis involved comparing Myah measurements with the Myopia Master system in a subgroup of 30 eyes using Bland-Altman plots and paired t-tests.

Main Results:

• The Myah device exhibited high repeatability, with intraclass correlation coefficients (ICC) ≥ 0.971 for all parameters.
• Repeatability (Sw) values were 0.018 D (K1), 0.021 D (K2), 0.071 mm (WTW), and 0.017 mm (AL).
• Good agreement was found for K1 (p=0.16) and AL (p=0.009), with some statistically significant differences noted for K2 (p<0.001) and WTW (p<0.001) between devices, though clinically acceptable.

Conclusions:

• The Myah device provides consistent and repeatable biometric measurements in a healthy pediatric population.
• Its measurements of corneal radius, WTW distance, and AL are validated for clinical use in children.
• The Myah device can be used interchangeably with the Myopia Master, with minor considerations for K2 and WTW measurements.