High‐frequency ultrasound point‐of‐care device to quantify myopia‐induced microstructural changes in the anterior sclera.

UNITED States. Food & Drug Administration; SCLERA; ULTRASONIC imaging; POINT-of-care testing; DATA warehousing; EYE examination; PHOTOREFRACTIVE keratectomy

Purpose: To develop a point‐of‐care (POC) device using high‐frequency ultrasound (US) for evaluating microstructural changes in the anterior sclera associated with myopia. Methods: The proposed POC device must satisfy four primary requirements for effective clinical use: the measurement component is handheld; the software must be simple and provide real‐time feedback; patient safety and health data security requirements set forth by relevant governing bodies must be satisfied and the measurement data must have sufficient signal‐to‐noise ratio (SNR) and repeatability. Radiofrequency (RF) echo data acquired by the POC device will be processed using our quantitative US methods to characterise tissue microstructure and biomechanical properties. Results: All stated requirements have been met in the developed POC device. The high‐frequency transducer is housed in a custom, 3D‐printed, pen‐like holder that allows for easy measurements of the anterior sclera. Custom software provides a simple interface for data acquisition, real‐time data display and secure data storage. Exposimetry measurements of the US pressure field indicate device compliance with United States Food and Drug Administration limits for ophthalmic US. In vivo measurements on a volunteer suggest the RF data SNR and acquisition consistency are suitable for quantitative analysis. Conclusions: A fully functioning POC device using high‐frequency US has been created for evaluating the microstructure of the anterior sclera. Planned studies using the POC device to scan the eyes of myopia patients will help clarify how the anterior sclera microstructure may be affected by myopia. If effective, this portable, inexpensive and user‐friendly system could be an important part of routine eye examinations. [ABSTRACT FROM AUTHOR]

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