Clinical Validation Study Protocol for SmartEyes Smart Optometry Measurement Device (Medical Device Clinical Validation Study)

Overview

This study aims to evaluate the SmartEyes smart refraction measurement device in two phases under real outpatient optometry room visits at Wuhan Children's Hospital. The first phase used a prospective, single-center, stratified paired cross-sectional clinical validation design, evaluating the consistency between SmartEyes, Topcon KR-800, and subjective refraction/post-dilation refraction results among outpatient children and adolescents without and those requiring dilation, and evaluating the repeatability of the three devices under corresponding conditions. The second phase added prospective cohort follow-up to explore the relationship between SmartEyes fine scale refractive data and axial length growth, evaluating whether these results better match or predict short-term axial growth trends than traditional 0.25D stepped objective refraction results.

This prospective, single-center, non-interventional clinical validation study is designed to systematically evaluate the clinical performance, accuracy, repeatability, and functional utility of the SmartEyes optometric measurement device in pediatric and adolescent outpatient settings. The study enrolls pediatric and adolescent subjects presenting for routine optometric examinations, covering a diverse spectrum of refractive statuses, including myopia, hyperopia, and astigmatism. The research design is structured into distinct phases and cohorts to thoroughly assess device performance under varying physiological conditions: Phase I (Cross-Sectional Evaluation): Subjects are allocated into two parallel subgroups based on clinical routine and requirements: Non-Cycloplegic Subgroup: Subjects complete two independent measurements with each of the three devices (Topcon KR-800, and the SmartEyes device) within a single visit, followed by subjective refraction. Between consecutive measurements, subjects are required to leave the chin/forehead rest and reposition to verify device repeatability. SmartEyes outputs its refractive results after completing its built-in optical eye relaxation protocol. Cycloplegic Subgroup: Subjects undergo one measurement with each of the three devices prior to cycloplegia. Following routine clinical cycloplegia/ciliary muscle paralysis and subsequent subjective refraction, subjects complete two additional independent measurements with each of the three devices to evaluate repeatability and agreement under cycloplegic conditions. (Note: No extra or study-mandated cycloplegic drugs are administered solely for research purposes). Phase II (Follow-up Evaluation): Conducts longitudinal tracking and follow-up assessments to evaluate the ongoing stability and consistency of the measurement devices over time. To thoroughly validate the device's diagnostic capabilities, the study focuses on primary evaluation dimensions including accuracy validation (assessing agreement of sphere, cylinder, axis, spherical equivalent, and corneal curvature via Bland-Altman analysis, ICC, and Pearson correlation), repeatability validation through consecutive independent scans, and the assessment of adaptive optical relaxation functions. This study does not involve any investigational drugs, invasive procedures, or alterations to standard clinical care pathways. The generated data will establish robust clinical evidence supporting the device's accuracy and stability, while providing standardized datasets for the continuous optimization of artificial intelligence-driven optometric algorithms and smart assistance platforms.