The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Subject Reported Eye Fatigue
研究概览
简要总结
Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a combination of these or other causes. The current study aims to systematically investigate the incremental benefits in ameliorating eye fatigue.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported "eye fatigue" at least once per week attributable to digital device use with baseline.
- •Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day
- •Mobile digital device with active data and text plan, able to receive email and text messages
- •Habitual 2-week or monthly silicone single vision hydrogel soft contact lens use; habitually wearing lenses for 6 or more hours per day for 5 or more days per week for the past 30 days
- •Habitual soft contact lens prescription optimized over-refraction within ±0.25 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.
排除标准
- •A habitual wearer of any of the test lenses
- •Any active conditions that may prevent soft contact lens wear.
- •Any doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
- •Any doctor diagnosed, self-reported accommodative or binocular vision issues
- •History of issues of eye alignment or binocularity by self-report
结局指标
主要结局
Subject Reported Eye Fatigue
时间窗: 1 week
Subjective Rating of Eye Fatigue, response to question "How would you rate your overall eye fatigue/tiredness?" on a 0-100 slider visual analog scale, where 0 represents 'Not Noticeable' and 100 represents 'Very Noticeable', with the numerical representation of their visual analog selection displayed to the right of the slider scale. Score reported is rating as described above.
次要结局
未报告次要终点
研究者
Pete Kollbaum, OD, PhD
Principal Investigator
Indiana University