Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change from Baseline meibography score at 1 week
研究概览
简要总结
To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after cataract surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age-related cataract
- •dry eye disease
排除标准
- •a history of surgery and other ocular diseases
- •contact lens use
- •ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months. had 4.any systemic diseases such as heart diseases, diabetes and psychosis.
结局指标
主要结局
Change from Baseline meibography score at 1 week
时间窗: 0 day, 1 week postoperative
meibography score
Change from Baseline noninvasive tear breakup time at 1 week
时间窗: 0 day, 1 week postoperative
noninvasive tear breakup time
Change from Baseline of non-invasive keratograph tear meniscus height at 1 month
时间窗: 0 day, 1 month postoperative
non-invasive keratograph tear meniscus height
Change from Baseline meibography score at 1 month
时间窗: 0 day, 1 month postoperative
meibography score
Change from Baseline noninvasive tear breakup time at 1 month
时间窗: 0 day, 1 month postoperative
noninvasive tear breakup time
Change from Baseline IL-1, IL-6, IL-12, IL-10, IL-8, TNF-α and ICAM-1 level at 1 month
时间窗: 0 day and 1 month postoperative
cytokine levels
Change from Baseline Ocular Surface Disease Index at 1 week
时间窗: 0 day, 1 week postoperative
Ocular Surface Disease Index
Change from Baseline of non-invasive keratograph tear meniscus height at 1 week
时间窗: 0 day, 1 week postoperative
non-invasive keratograph tear meniscus height
Change from Baseline Schirmer I test at 1 week
时间窗: 0 day, 1 week postoperative
Schirmer I test
Change from Baseline Ocular Surface Disease Index at 1 month
时间窗: 0 day, 1 month postoperative
Ocular Surface Disease Index
Change from Baseline Schirmer I test at 1 month
时间窗: 0 day, 1 month postoperative
Schirmer I test
slit-lamp examination
时间窗: 0 day
slit-lamp examination
次要结局
未报告次要终点