A Prospective Clinical Study to Evaluate the Repeatability of the Visibly Vision Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Visibly
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Test-retest variability (repeatability) of the Visibly Vision Test in the measurement of refractive error as assessed by the repeatability standard deviation using the Visibly software numerical outputs of estimated refractive error/correction.
研究概览
简要总结
The study is a prospective, multi-center, single-arm, non-randomized, non-blinded, observational study to evaluate the test-retest reliability of the Visibly Vision Test.
Additionally, observational data will be collected to understand whether the subject performs the set-up process correctly and subject comprehension of the patient labeling will also be evaluated.
详细描述
Potentially eligible subjects who provide informed consent and are confirmed qualified will be presented a room simulating the home environment with, at minimum, a table; pair of internet-connected devices (if subject has not opted to use their own), as well as some common household items. Subjects will then be directed to visit the website clinical.opternative.com and follow instructions on the website to complete vision testing.
Following completion of the first test session, subjects will undergo a series of critical knowledge task questions administered by site staff to evaluate their understanding of the critical aspects of the proposed patient labeling. Subjects will not receive verbal feedback and the study staff will refrain from any non-verbal responses to the answers provided from the subjects.
At least four hours but not more than 72 hours from the completion of the first test, each subject will be asked to return to the testing room, and complete the Visibly Vision Test again, including repeating the on-boarding, set-up, test, and off-boarding processes.
Site staff will observe and document the second testing process in the same manner as for the subject's first test session.
Following completion of the second test (retest), subject participation will be considered complete.
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
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 22 to 55 years at the time of consent;Recent (within 24 months) in-person comprehensive eye examination with a licensed eyecare professional and have prior prescription values (sphere, cylinder, axis) available;Subject must have either documented recent refractive error not greater than -1.00D of myopia and no greater than -2.00D astigmatism in either eye or documented prior correction no greater than -6.00D of myopia in either eye. Subject are without known existing eye disease or history of systemic disease that may affect the eye; Subjects with known BCVA of 20/32 or better per recent prescription
排除标准
- •Subject has had prior use of the Visibly Vision Test; Subjects with known diabetes mellitus; Subjects using ophthalmic or systemic corticosteroids; Subjects with known autoimmune conditions (e.g. Grave's disease, rheumatoid arthritis); Subjects with active corneal or conjunctival infection;Subjects with active corneal, conjunctival, or intraocular inflammation (i.e., uveitis); Subjects with known diabetic retinopathy; Subjects with known glaucoma or ocular hypertension; Subjects with known macular degeneration; Subjects with previous ocular surgery; Subjects using antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex); Subjects with a history of measured spherical difference between left and right eye of 4.00 D or greater;
研究组 & 干预措施
Cohort 1
Without using an available refractive correction and whose refractive error is no greater than -1.00D of myopia (spherical component in minus cylinder format) and with no greater than -2.00D of astigmatism in either eye
干预措施: Visibly Vision Test (Device)
Cohort 2
With prior correction of no greater than -6.00D of myopia (spherical component in minus cylinder format) and require a spherical (non-astigmatic) over-refraction of no more than ±1.00 D in either eye
干预措施: Visibly Vision Test (Device)
结局指标
主要结局
Test-retest variability (repeatability) of the Visibly Vision Test in the measurement of refractive error as assessed by the repeatability standard deviation using the Visibly software numerical outputs of estimated refractive error/correction.
时间窗: Retest conducted between four and 72 hours after initial test.
The refractive error measurements will be those given by the Visibly software numerical outputs of estimated refractive error/correction. For each component of the refractive error measured in diopters (sphere, cylinder, and spherical equivalent), the homogeneous repeatability will be assessed using repeated measurements within study eyes.
次要结局
- Collection of subject comprehension of critical aspects of patient labeling using subject response forms.(Performed immediately after initial test completion)