Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Visual Acuity During Head Tilt
研究概览
简要总结
The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.
详细描述
Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study, ~2 hour duration.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be at least 18 and less than or equal to 50 years of age
- •be able and willing to adhere to the instructions set forth in the protocol.
- •have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D
- •Sign the STATEMENT OF INFORMED CONSENT.
- •Have normal, healthy eyes
排除标准
- •The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear.
- •Pre-existing ocular disease precluding contact lens fitting.
- •Insufficient lacrimal secretions
- •Aphakia, keratoconus or a highly irregular cornea
- •Previous eye surgery involving the anterior segment
- •Current pregnancy or lactation (to the best of the subject's knowledge).
- •Use of concurrent ocular medication
- •Active participation in another clinical study at any time during this study.-
结局指标
主要结局
Visual Acuity During Head Tilt
时间窗: after each of the four lens insertions
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
Lens Orientation During Head Tilt.
时间窗: after fit of each of the four lens insertions
Degree of lens rotation on the eye with the head tilted.
次要结局
- Degree of Lens Rotation in Temporal Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation in Superior Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation in Superior-temporal Gaze.(After each of 4 lens insertions.,)
- Degree of Lens Rotation in Inferior Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation Inferior-temporal Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation in Superior-nasal Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation in Nasal Gaze.(After each of the four lens insertions)
- Degree of Lens Rotation in Inferior-nasal Gaze.(After each of the four lens insertions)