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

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.

Inclusion criteria

• Aged 6-17 years old, no gender limit;
• Visiting the outpatient optometry room of Wuhan Children's Hospital, clinically required refraction examination;
• Ability to cooperate in completing SmartEyes, Topcon KR-800, Topcon KR-1W examinations;
• Able to complete reliable subjective refraction;
• Subjects in the mydriasis subgroup should be those who need mydriasis/cycloplegia refraction for clinical diagnosis and treatment;
• Those who participate in the second phase cohort must be able to complete the axial length measurement and be willing to return to complete the 3-month (and 6-month) follow-up as planned;
• Guardians are fully informed and sign written informed consent;
• Subject children accept research notifications based on their age and understanding ability, and express agreement or no objection to participating in the research.

Exclusion criteria

• Those unable to maintain stable fixation, unable to cooperate with desktop equipment for examination, or unable to perform reliable subjective refraction;
• Obvious strabismus, nystagmus, severe amblyopia, or other conditions affecting the reliability of objective/subjective refraction;
• Keratoconus, obviously irregular astigmatism, corneal scarring, corneal edema, or other corneal diseases that significantly affect refractive measurement;
• Moderate to severe cataracts, obvious lens opacity, vitreous opacity, fundus diseases, and other conditions that may affect the refraction endpoint;
• History of previous corneal refractive surgery or intraocular surgery;
• Still wearing orthokeratology lenses, RGP, or other contact lenses on the day and determined by the investigator to affect measurement results;
• Participants in the second phase cohort who are unable to complete follow-up, plan to undergo eye surgery in the short term, or have investigators who judge axial measurement results to be clearly unreliable will not be included in the cohort follow-up analysis;
• Other circumstances where the investigator determines the participant is unsuitable for this study.