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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Refractive Measurement Agreement and Repeatability across Subgroups
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: SmartEyes smart refraction measuring device (Device)
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.
干预措施: Topcon KR800 (Device)
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.
干预措施: Subjective refraction (Diagnostic Test)
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.
干预措施: SmartEyes smart refraction measuring device (Device)
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.
干预措施: Topcon KR800 (Device)
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.
干预措施: Subjective refraction (Diagnostic Test)
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.
干预措施: SmartEyes smart refraction measuring device (Device)
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.
干预措施: Topcon KR800 (Device)
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.
干预措施: Subjective refraction (Diagnostic Test)
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.
干预措施: IOL master 700 (Device)
结局指标
主要结局
Refractive Measurement Agreement and Repeatability across Subgroups
时间窗: 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.
次要结局
- Correlation between fine-graded refractive change and absolute axial length change(From baseline through the Phase II longitudinal follow-up period (6 months))
- 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))