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

NCT07803094 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: SE-202608
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Refractive Errors

Keywords

Refractometers; Ophthalmologic Diagnostic Techniques; Reproducibility of Results; Validation Study; Pediatric Optometry

Outcome Measures

Primary Outcomes (1)

• 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.

  Phase I clinical evaluation (completed during the baseline outpatient examination sessions)

Secondary Outcomes (3)

• Absolute axial length change measured by optical biometry

  From baseline through the Phase II longitudinal follow-up period (6 months)

• Axial length growth rate measured by optical biometry

  From baseline through the Phase II longitudinal follow-up period (6 months)

• Correlation between fine-graded refractive change and absolute axial length change

  From baseline through the Phase II longitudinal follow-up period (6 months)

Study Arms (3)

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.

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.

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.

Device: SmartEyes smart refraction measuring device; Device: Topcon KR800; Diagnostic Test: Subjective refraction; Device: IOL master 700

Interventions

Topcon KR800 DEVICE

Used to acquire objective optometric parameters, including refractive errors and corneal measurements, during the clinical evaluation and comparison protocol.

Follow-up visit group （Phase II); No pupil dilation subgroup（Phase I); Required pupil dilation subgroup（Phase I)

SmartEyes smart refraction measuring device DEVICE

Used to acquire objective optometric parameters, including refractive errors and corneal measurements, during the clinical evaluation and comparison protocol.

Follow-up visit group （Phase II); No pupil dilation subgroup（Phase I); Required pupil dilation subgroup（Phase I)

Subjective refraction DIAGNOSTIC_TEST

Routine refractive examination

Follow-up visit group （Phase II); No pupil dilation subgroup（Phase I); Required pupil dilation subgroup（Phase I)

IOL master 700 DEVICE

FDA-certified equipment used for measuring the axial length

Follow-up visit group （Phase II)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adolescent outpatients presenting for routine optometric examinations and refractive status evaluation at the clinical site.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Hong Jie, MD

  Wuhan Children's Hospital affiliated with Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Mingguang He

  The Hong Kong Polytechnic University

  STUDY CHAIR

Central Study Contacts

Jijing Li, MD, PhD

CONTACT

027-83627088; jijing.li@cevr.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 3, 2026
• Study Start: August 28, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): June 2, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share