NCT03881670已完成4 期
On-Eye Optical Quality of Lotrafilcon B Lenses Over 12 Hours
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Higher Order Aberrations
研究概览
简要总结
The current study aims to systematically investigate the diurnal variation in the optical quality of soft contact lenses on eye throughout the day. Subject reported quality of vision will also be evaluated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Habitual prescription +5.00 D to -6.00 D
- •18-35 years of age
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Vertex corrected refractive cylinder must be -0.75 or less.
- •Visual acuity best correctable to 20/25 or better for each eye
- •The subject must read and sign the Informed Consent form.
- •Mesopic pupil size >5.00 mm.
排除标准
- •active condition that would prevent contact lens wear
- •history of issues of eye alignment or binocularity by self-report
- •doctor diagnosed, self-reported accommodative or binocular vision issues
- •doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
结局指标
主要结局
Higher Order Aberrations
时间窗: 0-12 hours
Higher-order Root Mean Squared (RMS) over a 3mm pupil; difference in RMS error between 0 and 12 hour timepoints; averaged across all subjects
次要结局
- Image Quality Metrics(0-12 hours)
- Subjective Stability of Vision Rating(0-12 hours)
研究者
Pete Kollbaum, OD, PhD
Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research
Indiana University
研究点 (2)
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