Clinical Efficacy of Wireless Micropump in Dry Eye Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- tear film break-up time
研究概览
简要总结
The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment should be the same for each patient, and this will limit the variations within a study.
详细描述
The purpose of this study is to carry out a trial to get more convincing and valuable results of the wireless micropump in dry eye patients and compare the outcomes before and after eye drops usage. The investigators hope to investigate the micropump comprehensively, including the comparison of tear film break-up time, corneal epithelium defect percentage, and tear film thickness. To meet the demands of a trial, all the examination equipment and methods should be the same for each patient, and this will limit the variations within a study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •elimination of serious mental and psychological diseases;
- •be accompanied by a parent or guardian who is able to give informed consent as demonstrated by signing a record of informed consent;
- •be willing to comply with the clinical trial visit schedule as directed by the investigator;
- •at baseline, be within the age range of 18 to 80 years old inclusive;
- •BCVA≥1.0 of both eyes for each patient;
- •dry eye test is BUT<5s and or Schimer test<5mm/5min；
- •without other ophthalmic diseases;
排除标准
- •At the same time, patients with other eye diseases (such as glaucoma, corneal opacity, uveitis, etc.) were diagnosed;
- •serious mental and psychological diseases;
- •history of refractive surgery;
- •nystagmus or failure to cooperate;
- •history of intraocular surgery;
- •patients with systemic diseases (such as diabetes, hypertension, heart disease, etc.)
研究组 & 干预措施
sodium hyaluronate
Sodium hyaluronate has become a novel and effective eye drop for the treatment of the dry eye. However, we design a special method of usage of sodium hyaluronate in dry eye patients.
干预措施: Sodium Hyaluronate (Drug)
结局指标
主要结局
tear film break-up time
时间窗: change from baseline with OCCULUS at 6 months
change before and after sodium hyaluronate with OCCULUS
tear film thickness
时间窗: change from baseline with OCCULUS at 6 months
change before and after sodium hyaluronate with OCCULUS
corneal epithelium defect percentage
时间窗: change from baseline with OCCULUS at 6 months
change before and after sodium hyaluronate with OCCULUS
次要结局
未报告次要终点