Toric Contact Lens Performance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Near Visual LogMAR Acuity
研究概览
简要总结
This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.
详细描述
This is a prospective, single site, randomized, masked, crossover study. This study will evaluate the ability of toric contact lenses to decrease signs and symptoms of asthenopia and improve digital reading performance. Symptoms and objective near vision outcomes will be measured at baseline and after 1 week of wear with each correction.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •+6.00 to -6.00 D vertexed sphere power and -0.75 to -1.50 D vertexed refractive cylinder in the right and left eyes Best corrected acuity of 20/25 or better in each eye Self report of at least 4 hrs/day using digital devices Current/established soft contact lens wearer (has worn contact lenses in the past year)
- •Exclusion An optometrist or optometry student History of ocular pathology or surgery Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency) Gas permeable lens wear for at least 3 months Presbyopic (based on refraction)
排除标准
- 未提供
研究组 & 干预措施
Sphere, Then Toric
Participants who received Spherical contact lenses first and Toric lenses after 10 days
干预措施: Dailies Aqua Comfort Plus Toric (Device)
Sphere, Then Toric
Participants who received Spherical contact lenses first and Toric lenses after 10 days
干预措施: Dailies Aqua Comfort Plus Sphere (Device)
Toric, Then Sphere
Participants who received Toric contact lenses first and spherical lenses after 10 days
干预措施: Dailies Aqua Comfort Plus Toric (Device)
Toric, Then Sphere
Participants who received Toric contact lenses first and spherical lenses after 10 days
干预措施: Dailies Aqua Comfort Plus Sphere (Device)
结局指标
主要结局
Near Visual LogMAR Acuity
时间窗: 10 +/- 2 days
High contrast LogMAR visual acuity was assessed at 40 cm using the M\&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly. The test started at 20/200 and continued until three letters were missed on a line.
次要结局
未报告次要终点
研究者
Kathryn Richdale
Associate Professor
University of Houston