Effect of Treatment With Systane Ultra in Symptomatology and Visual Task Efficiency in Digital Device Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- OSDI Score
研究概览
简要总结
This study assessed the effect of one month of use of preservative-free artificial tears (Systane Ultra UD, Alcon) on symptomatology related to digital eye strain (DES), visual task performance, and tear film stability in visual display terminal users.
详细描述
Visual display terminal users (>4h/day) with DES (CVSS17 score: ranged 29 to 42) and dryness (OSDI score: ranged 13 to 24) symptomatology were prescribed with preservative-free artificial tears (Systane Ultra UD, Alcon) four times a day for one month collecting OSDI and CVSS17 questionnaires in four visits [screening (Day -7), initial (Day 0), one week (Day 7) and one month (Day 30)].
Blink rate and number of eye fixations (collected with eye-tracker) in six simple computer tasks and out-loud reading speed were determined before and after performing all tasks on the computer. Tear film stability and ocular parameters were also measured.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer subjects of legal age will be included who agree to participate in the study after being informed by the researcher, receiving the information sheet and signing the informed consent.
- •Eye discomfort related to dryness (OSDI score ranged from 13 to 24)
- •Symptomatic digital device users (CVSS17 score ranged from 29 to 42 points - stages 3 and 4)
- •Use of computer continuously for at least 4 hours per day (work week)
- •Good best-corrected visual acuity (Visual acuity LogMar ≤ 0.00 for distance, intermediate (60cm) and near (40cm))
排除标准
- •Systemic administration of drugs with a possible effect on the ocular surface.
- •Topical administration of any drugs that can alter the ocular surface.
- •Use of contact lenses
- •Use of artificial tears or lubricants at least 7 days before inclusion in the study (recruitment visit).
- •Any other ocular pathology or binocular conditions which may cause discomfort (e.g. heterophoric, accommodative, and eye movement disorders)
结局指标
主要结局
OSDI Score
时间窗: One month
Change in OSDI score
CVSS17 Score
时间窗: One month
Change in CVSS17 score
次要结局
未报告次要终点
研究者
Raul Martin Herranz
PhD
University of Valladolid