Clinical Validation Study Protocol for SmartEyes Smart Optometry Measurement Device (Medical Device Clinical Validation Study) (CVSP-SOMD)
2 settembre 2026 aggiornato da: The Hong Kong Polytechnic University
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.
Panoramica dello studio
Stato
Stato
Non ancora reclutamento
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Osservativo
Iscrizione (Stimato)
Iscrizione
200
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
Contatto studio
- Nome: Jijing Li, MD, PhD
- Numero di telefono: 027-83627088
- Email: jijing.li@cevr.hk
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Pediatric and adolescent outpatients presenting for routine optometric examinations and refractive status evaluation at the clinical site.
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Numero di gruppi/coorti
3
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
|
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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Refractive Measurement Agreement and Repeatability across Subgroups
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Absolute axial length change measured by optical biometry
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Hong Jie, MD, Wuhan Children's Hospital affiliated with Tongji Medical College, Huazhong University of Science and Technology
- Cattedra di studio: Mingguang He, The Hong Kong Polytechnic University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
Inizio studio
28 agosto 2026
Completamento primario (Stimato)
Completamento primario
2 febbraio 2027
Completamento dello studio (Stimato)
Completamento dello studio
2 giugno 2027
Date di iscrizione allo studio
Primo inviato
Primo inviato
21 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
2 settembre 2026
Primo Inserito (Effettivo)
Primo Inserito
3 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
3 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
2 settembre 2026
Ultimo verificato
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- SE-202608
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .