Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patients With Meibomian Gland Dysfunction Prior to Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- TBUT
研究概览
简要总结
Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery.
详细描述
IPL procedure is a device used for symptom relief and treatment of dry eye syndrome caused by meibomian gland dysfunction in adults, and its safety and long-term effects have been confirmed. The purpose of this study is to determine whether this procedure before cataract surgery is effective in improving the symptoms of dry eye syndrome 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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A patient at the age of 21 cataract surgery
- •A patient has the visual potential of 20/25 or better in each eye after cataract removal
- •Dry eye patient by meibomian gland dysfunction
- •Written informed consent to surgery and participation in the study
排除标准
- •Eye damage, active eye infection
- •Uncontrolled health problem
- •Wear contact lens within one month
- •Allergic reactions of fluorescein sodium or ophtalmic anesthetic
- •Eye surgery and trauma in the last six months
- •Eye disease, structural abnormality
- •If there is a cause of vision loss other than cataracts
- •Under 20/25 expect vision
- •Under the age of 20 years of age
- •Pregnant woman and lactating woman
- •Medical conditions in which IPL is contraindicated
结局指标
主要结局
TBUT
时间窗: 3 months
tear break-up time
meibomian gland function score
时间窗: 3 months
By expression of eyelid, scoring of expressibility and quality of meibum will be tested. Form of secretion predominantly secreted by the eight meibomian glands in the center of the lid was evaluated as follows. grade 0, clear meibum is easily expressed; grade 1, cloudy meibum is expressed with mild pressure; grade 2, cloudy meibum is expressed with more than moderate pressure; and grade 3, meibum cannot be expressed even with the hard pressure. Higher score means a worst outcome.
次要结局
- OSDI(3 months)
- Corneal staining score(3 months)
研究者
tae-young chung
Professor
Samsung Medical Center