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.
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;
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;
Pediatric and adolescent outpatients presenting for routine optometric examinations and refractive status evaluation at the clinical site.
Cohort
Prospective
SmartEyes smart refraction measuring device
DeviceUsed to acquire objective optometric parameters, including refractive errors and corneal measurements, during the clinical evaluation and comparison protocol.
Topcon KR800
DeviceUsed to acquire objective optometric parameters, including refractive errors and corneal measurements, during the clinical evaluation and comparison protocol.
Subjective refraction
Diagnostic testRoutine refractive examination
IOL master 700
DeviceFDA-certified equipment used for measuring the axial length
Refractive Measurement Agreement and Repeatability across Subgroups
Evaluate the agreement between SmartEyes, Topcon KR-800, and subjective/cycloplegic reference refractions, as well as the independent measurement repeatability of each device, across both non-cycloplegic and cycloplegic subgroups. Assess whether the optical eye relaxation function of SmartEyes yields refractive outcomes closer to subjective and cycloplegic references than conventional objective methods.
Absolute axial length change measured by optical biometry
Absolute change in axial length (unit: mm) measured by optical biometry device.
Axial length growth rate measured by optical biometry
Axial length monthly growth rate (unit: mm/month), derived from serial axial-length measurements obtained by optical biometry device.
Correlation between fine-graded refractive change and absolute axial length change
Pearson correlation coefficient between fine-graded spherical equivalent change (SmartEyes autorefractor, diopter) and absolute axial-length change (optical biometry, mm).
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