NCT04811079已完成不适用
The Role of Spectral Filtering in a Spectrally Adjustable Ocular Photosensitivity Analyzer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Visual Photosensitivity Threshold (VPT)
研究概览
简要总结
This is a 6-visit, single-center, non-dispensing, randomized, single-masked, 5×5 crossover study. Subjects will participate in 6 scheduled over the duration of approximately 10.5 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •The subject must read and sign the Informed Consent form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Healthy adult males or females age ≥18 and ≤30 years of age.
- •Normal color vision as measured using the Ishihara 38-plate test.
- •Normal stereopsis as measured by a suitable test.
- •Auto-refraction must show a spherical component of -2.00 through +2.00 D, and a cylindrical component of 0.00 through 1.50 D.
- •The subject's distance refractive sphere must be between -2.00 and +2.00 D in each eye.
- •The subject's distance refractive cylinder must be ≤ 1.50 D in each eye.
- •The subject must have unaided distance Snellen visual acuity of 20/200 or better for each eye.
- •The subject must have best corrected distance Snellen visual acuity of 20/25 or better for each eye.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •History of refractive surgery or other ocular surgery.
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •Subjects that participated in the pilot study CR-
- •Systemic conditions or the use of medications that the investigator believes will contraindicate participation in this study.
- •Abnormal Level 3 neuro-ophthalmology exam including crystalline lens clarity Grade 3 or worse (Lens Opacities Classification System).
- •Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale.
结局指标
主要结局
Visual Photosensitivity Threshold (VPT)
时间窗: at approximately 2-week follow-up
VPT will measured via the SAOPA instrument. VPT is the point at which a sensation of pain or discomfort occurs when the intensity of light is gradually increased from a low level. Subject's discomfort responses will be indicated via a button press. Testing is complete when 10 response reversals are acquired.
次要结局
未报告次要终点
研究者
研究点 (2)
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