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NCT07803094

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

Sponsor: The Hong Kong Polytechnic University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-08-28

Completion Date

2027-06-02

Last Updated

2026-09-03

Healthy Volunteers

Conditions

Refractive Errors

Interventions

DEVICE

SmartEyes smart refraction measuring device

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

DEVICE

Topcon KR800

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

DIAGNOSTIC_TEST

Subjective refraction

Routine refractive examination

DEVICE

IOL master 700

FDA-certified equipment used for measuring the axial length

Inclusion Criteria: 1. Aged 6-17 years old, no gender limit; 2. Visiting the outpatient optometry room of Wuhan Children's Hospital, clinically required refraction examination; 3. Ability to cooperate in completing SmartEyes, Topcon KR-800, Topcon KR-1W examinations; 4. Able to complete reliable subjective refraction; 5. Subjects in the mydriasis subgroup should be those who need mydriasis/cycloplegia refraction for clinical diagnosis and treatment; 6. 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; 7. Guardians are fully informed and sign written informed consent; 8. 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: 1. Those unable to maintain stable fixation, unable to cooperate with desktop equipment for examination, or unable to perform reliable subjective refraction; 2. Obvious strabismus, nystagmus, severe amblyopia, or other conditions affecting the reliability of objective/subjective refraction; 3. Keratoconus, obviously irregular astigmatism, corneal scarring, corneal edema, or other corneal diseases that significantly affect refractive measurement; 4. Moderate to severe cataracts, obvious lens opacity, vitreous opacity, fundus diseases, and other conditions that may affect the refraction endpoint; 5. History of previous corneal refractive surgery or intraocular surgery; 6. Still wearing orthokeratology lenses, RGP, or other contact lenses on the day and determined by the investigator to affect measurement results; 7. 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; 8. Other circumstances where the investigator determines the participant is unsuitable for this study.

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria