An Exploratory Study in Healthy Adult Volunteers to Evaluate the Best Corrected Visual Acuity (BCVA) Performance of a Handheld Device Compared With a Standard Eye Care Diagnostic Device in Measuring Ophthalmic Refraction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants
研究概览
简要总结
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.
详细描述
This study is exploratory and examines whether the best-corrected visual acuities (BCVA's) from trial frames created with the refraction results obtained from a novel handheld optical device yields results similar to the ophthalmic refraction obtained from an autorefractor in healthy volunteers age stratum of 18 through 65 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Tester and subject for BCVA are masked as to which device and trial frames are from.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Ages =>18 y.o. and =<65 y.o.
- •Binocular vision
- •Willing and able to give informed consent and follow all study procedures and requirements
- •Fluent in English
排除标准
- •Has been diagnosed within 4 weeks, or currently has signs or symptoms, of COVID-
- •Has traveled outside the country within the last 4 weeks.
- •At the discretion of the investigator: Age strata has achieved minimum evaluable population.
- •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-reported mental illness or condition, including but not limited to:
- •claustrophobia, fear of simulators, nyctophobia.
- •Any self-reported neurological diseases, including but not limited to: epilepsy, Alzheimer's, nystagmus
- •Per subject self-reporting: 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
- •Subjects that:
- •Lack physical dexterity to properly operate the EyeQue device.
- •Lack the ability to follow instruction
- •Lack a command of the English language
- •Lack binocular vision
- •Are colorblind
- •Had eye surgery within the last 12 months (including Lasik)
结局指标
主要结局
Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor for all participants
时间窗: Day 1
Tendency of, or achieving, statistical non-inferiority of EyeQue EQ103 BCVA's (reading an EDTRS chart) for each eye from (pooled) trial frames created with the refraction values compared with those of an autorefractor analyzed with all age groups.
次要结局
- Best corrected visual acuity (BCVA) for worse eye: EQ103 vs Autorefractor for all subjects and age groupings(Day 1)
- Best corrected visual acuity (BCVA) for both eyes EQ103 vs Autorefractor examining age groupings(Day 1)