Clinical Validation Study Protocol for SmartEyes Smart Optometry Measurement Device (Medical Device Clinical Validation Study) (CVSP-SOMD)
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
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jijing Li, MD, PhD
- Phone Number: 027-83627088
- Email: jijing.li@cevr.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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
|
|
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.
|
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
|
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Phase I clinical evaluation (completed during the baseline outpatient examination sessions)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absolute axial length change measured by optical biometry
Time Frame: From baseline through the Phase II longitudinal follow-up period (6 months)
|
Absolute change in axial length (unit: mm) measured by optical biometry device.
|
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)
|
Axial length monthly growth rate (unit: mm/month), derived from serial axial-length measurements obtained by optical biometry device.
|
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)
|
Pearson correlation coefficient between fine-graded spherical equivalent change (SmartEyes autorefractor, diopter) and absolute axial-length change (optical biometry, mm).
|
From baseline through the Phase II longitudinal follow-up period (6 months)
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Collaborators and Investigators
Investigators
- Principal Investigator: Hong Jie, MD, Wuhan Children's Hospital affiliated with Tongji Medical College, Huazhong University of Science and Technology
- Study Chair: Mingguang He, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SE-202608
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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