An observational study in Refractive Errors, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by The Hong Kong Polytechnic University · Observational
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.
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 108 observational studies indexed under Refractive Errors.
Browse Refractive Errors studies →The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
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Pediatric and adolescent outpatients presenting for routine optometric examinations and refractive status evaluation at the clinical site.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No pupil dilation subgroup: Subjects completed two independent tests each of Topcon KR-800 and SmartEyes smart optometry devices during the same outpatient procedure, followed by subjective refraction. Between two independent tests, subjects were asked to leave the mandibular rest/forehead rest and reposition to verify the repeatability of each device. Each SmartEyes test outputs the refraction results after completing the device's built-in optical eye relaxation process.
Device: SmartEyes smart refraction measuring device · Device: Topcon KR800 · Diagnostic Test: Subjective refraction
Before pupil dilation, subjects completed one test each of Topcon KR-800, and SmartEyes devices; Then, following the routine outpatient procedures of Wuhan Children's Hospital, the clinically required pupil dilation/ciliary muscle palsy was completed, followed by subjective refraction after pupil dilation. After meeting clinical examination requirements, each of the three devices underwent two independent tests to evaluate repeatability and consistency under dilated pupil conditions. No additional mydriatic drugs were used for research purposes.
Device: SmartEyes smart refraction measuring device · Device: Topcon KR800 · Diagnostic Test: Subjective refraction
Subjects may be selected from those willing to continue follow-up in the first phase, or from newly screened eligible subjects in the same outpatient setting. All cohort subjects completed baseline refraction and axial measurement, followed up at 3 months (and 6 months). To reduce the impact of inspection sequence, the first phase uses a pre-established random sequence or balanced rotation sequence for the three devices; The dilation subgroup should try to maintain the same device sequence for the same subject before and after dilation. Final subjective optometry is performed by an experienced optometrist, who must not view the results of SmartEyes, or KR-800 before recording the subjective refraction endpoint.
Device: SmartEyes smart refraction measuring device · Device: Topcon KR800 · Diagnostic Test: Subjective refraction · Device: IOL master 700
Used to acquire objective optometric parameters, including refractive errors and corneal measurements, during the clinical evaluation and comparison protocol.
Used to acquire objective optometric parameters, including refractive errors and corneal measurements, during the clinical evaluation and comparison protocol.
Routine refractive examination
FDA-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.
Time frame: Phase I clinical evaluation (completed during the baseline outpatient examination sessions)
Absolute axial length change measured by optical biometry
Absolute change in axial length (unit: mm) measured by optical biometry device.
Time frame: From baseline through the Phase II longitudinal follow-up period (6 months)
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.
Time frame: From baseline through the Phase II longitudinal follow-up period (6 months)
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).
Time frame: From baseline through the Phase II longitudinal follow-up period (6 months)
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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