NCT04955379招募中不适用
An Exploratory Study in Healthy Pediatric Volunteers to Evaluate the Performance of a Handheld Device Compared With Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
EyeQue Corp.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年12月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
研究概览
简要总结
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.
详细描述
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in the age stratum of 6 through 17 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Ages ≥6 y.o. and <18 y.o.
- •Binocular vision
- •Parent(s) or Guardian(s) willing and able to give informed consent on behalf of the subject.
- •Subject able to follow all study procedures and requirements
排除标准
- •Spherical correction > +8 or < -10
- •Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study.
- •Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study.
- •Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the EyeQue EQ103 device,
- •Any self/caregiver-reported mental illness or condition of the subject, including but not limited to claustrophobia, fear of simulators, nyctophobia.
- •Any self/caregiver-reported neurological diseases of the subject, including but not limited to: epilepsy, nystagmus.
- •Any self/caregiver-reported glaucoma diagnosis of the subject.
- •Eye disease, including but not limited to:
- •Cataracts
- •Macular degeneration
- •Eye infection (by self-report or observation)
- •Keratoconus
- •Diabetic neuropathy/retinopathy
- •Cytomegalovirus retinitis
- •Color blindness (any color deficiency)
- •Diabetic macular edema
- •Amblyopia
- •Chronic or acute uveitis
- •Strabismus
- •Astigmatism > 3 diopters
- •Macular hole
- •Lack physical dexterity to properly operate the EyeQue device.
- •Lack the ability to follow instruction.
- •Lack binocular vision.
- •Are colorblind.
- •Had eye surgery within the last 12 months.
结局指标
主要结局
Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
时间窗: Day 1
Tendency of, or achieving, statistical equivalence of refraction measurements EQ103 (non-cycloplegic) compared with autorefractor (non-cycloplegic)
次要结局
- EQ103 without cycloplegia will be compared to EQ103 with cycloplegia by younger age-strata.(Day 1 and 14)
- EyeQue EQ103 (non-cycloplegic) and the autorefractor (cycloplegic) assessed by refractive error measured by each device analyzed by age-strata.(Day 1 and 14)
研究者
研究点 (2)
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