NCT04120389Unknown不适用
Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Complicated and Combined Cataract Surgery
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Schirmer test with anesthesia
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 complicated and combined 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cataract patients（age 40-80）
- •complex symptom（such as:corneal opacity、small pupil、zonule relaxationlens subluxation、Shallow Anterior Chamber、hypermature cataract、hard nucleus,etc）
- •dry eye disease
排除标准
- •simplex age-related cataract
- •contact lens use
- •ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months
- •any systemic diseases such as heart diseases, diabetes and psychosis
结局指标
主要结局
Schirmer test with anesthesia
时间窗: 3 months postoperatively
The Schirmer test was performed by inserting a test strip
Tear Breakup Time
时间窗: 3 months postoperatively
Tear Breakup Time was performed to assess tear film stability
Ocular Surface Disease Index questionnaire
时间窗: 3 months postoperatively
Ocular Surface Disease Index questionnaire were included 12 questions，and each was rated from 0-4
次要结局
- Fluorescein Staining(3 months postoperatively)
- Subjective symptoms(3 months postoperatively)
研究者
研究点 (1)
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