Refractive ErrorsCVSP-SOMDNCT07803094
Clinical Validation Study Protocol for SmartEyes Smart Optometry Measurement Device (Medical Device Clinical Validation Study)
An observational study of Refractive Errors, run by The Hong Kong Polytechnic University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Refractive Errors
- What is being tested?
- SmartEyes smart refraction measuring device, Topcon KR800 and Subjective refraction
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2026to 2 Jun 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric and adolescent outpatients presenting for routine optometric examinations and refractive status evaluation at the clinical site.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Validation Study of SmartEyes Smart Optometry Measurement Instrument for Objective Refraction Agreement, Repeatability, Optical Eye Relaxation Function, and Refractive Fine-Scale Prediction of Axial Length Growth in Pediatric and Adolescent Outpatient Refraction Settings
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.
Read the detailed description
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.
- Conditions
- Refractive Errors
- Being tested
- SmartEyes smart refraction measuring device, Topcon KR800, Subjective refraction, IOL master 700
- Keywords
- Refractometers, Ophthalmologic Diagnostic Techniques, Reproducibility of Results, Validation Study, Pediatric Optometry
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartEyes smart refraction measuring deviceDevice
Used to acquire objective optometric parameters, including refractive errors and corneal measurements, during the clinical evaluation and comparison protocol.
Topcon KR800Device
Used to acquire objective optometric parameters, including refractive errors and corneal measurements, during the clinical evaluation and comparison protocol.
Subjective refractionDiagnostic test
Routine refractive examination
IOL master 700Device
FDA-certified equipment used for measuring the axial length
| Study group | Role | What they receive |
|---|---|---|
| No pupil dilation subgroup（Phase I) | 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. Receives: Device: SmartEyes smart refraction measuring device; Device: Topcon KR800; Diagnostic Test: Subjective refraction | |
| Required pupil dilation subgroup（Phase I) | 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. Receives: Device: SmartEyes smart refraction measuring device; Device: Topcon KR800; Diagnostic Test: Subjective refraction | |
| Follow-up visit group （Phase II) | 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. Receives: Device: SmartEyes smart refraction measuring device; Device: Topcon KR800; Diagnostic Test: Subjective refraction; Device: IOL master 700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Phase I clinical evaluation (completed during the baseline outpatient examination sessions)
Secondary outcomes (3)
Absolute axial length change measured by optical biometry
Absolute change in axial length (unit: mm) measured by optical biometry device.
Measured: 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.
Measured: 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).
Measured: From baseline through the Phase II longitudinal follow-up period (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start28 Aug 2026 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Jie, MD, Principal investigator, Wuhan Children's Hospital affiliated with Tongji Medical College, Huazhong University of Science and TechnologyMingguang He, Study chair, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803094
- Sponsor's protocol ID
- SE-202608
- Acronym
- CVSP-SOMD
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation Study of SmartEyes Smart Optometry Measurement Instrument for Objective Refraction Agreement, Repeatability, Optical Eye Relaxation Function, and Refractive Fine-Scale Prediction of Axial Length Growth in Pediatric and Adolescent Outpatient Refraction Settings
- ClinicalTrials.gov ID
- NCT07803094
- Acronym / sponsor ID
- CVSP-SOMD / SE-202608
- Conditions
- Refractive Errors
- Keywords
- Refractometers, Ophthalmologic Diagnostic Techniques, Reproducibility of Results, Validation Study, Pediatric Optometry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No pupil dilation subgroup（Phase I) | – | Device: SmartEyes smart refraction measuring device, Device: Topcon KR800, Diagnostic Test: Subjective refractionNo 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. |
| Required pupil dilation subgroup（Phase I) | – | Device: SmartEyes smart refraction measuring device, Device: Topcon KR800, Diagnostic Test: Subjective refractionBefore 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. |
| Follow-up visit group （Phase II) | – | Device: SmartEyes smart refraction measuring device, Device: Topcon KR800, Diagnostic Test: Subjective refraction, Device: IOL master 700Subjects 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric and adolescent outpatients presenting for routine optometric examinations and refractive status evaluation at the clinical site.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartEyes smart refraction measuring deviceUsed to acquire objective optometric parameters, including refractive errors and corneal measurements, during the clinical evaluation and comparison protocol. | Device | Follow-up visit group （Phase II), No pupil dilation subgroup（Phase I), Required pupil dilation subgroup（Phase I) |
| Topcon KR800Used to acquire objective optometric parameters, including refractive errors and corneal measurements, during the clinical evaluation and comparison protocol. | Device | Follow-up visit group （Phase II), No pupil dilation subgroup（Phase I), Required pupil dilation subgroup（Phase I) |
| Subjective refractionRoutine refractive examination | Diagnostic test | Follow-up visit group （Phase II), No pupil dilation subgroup（Phase I), Required pupil dilation subgroup（Phase I) |
| IOL master 700FDA-certified equipment used for measuring the axial length | Device | Follow-up visit group （Phase II) |
Primary outcome
Refractive Measurement Agreement and Repeatability across Subgroups
Time frame: Phase I clinical evaluation (completed during the baseline outpatient examination sessions)
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.
3 secondary outcomes
Absolute axial length change measured by optical biometry
Time frame: From baseline through the Phase II longitudinal follow-up period (6 months)
Axial length growth rate measured by optical biometry
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
Time frame: From baseline through the Phase II longitudinal follow-up period (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong Jie, MD principal investigator
Wuhan Children's Hospital affiliated with Tongji Medical College, Huazhong University of Science and Technology
Mingguang He study chair
The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Errors, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jijing Li, MD, PhD (027-83627088, jijing.li@cevr.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Refractive Measurement Agreement and Repeatability across Subgroups (time frame: Phase I clinical evaluation (completed during the baseline outpatient examination sessions)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.