Stability of Biometry in Patients With Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Spherical and toric IOL power selected at baseline and at 3 months visit
研究概览
简要总结
Accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. However, some recent studies indicate that preoperative biometry is influenced by dry eye disease (DED). Hence, the investigator's study aims to investigate the effect of the therapy of MGD using the Lipiflow® device on the stability of biometry and selection of IOL.
详细描述
Accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. 31 Patients suffering from DED caused by MGD will be selected and allocated randomly to therapy. Patients with pre-existing DED therapy other than lubricants will be excluded. After completing prestudy-screening and baseline visit, Lipiflow® therapy is applied to the study eye. Follow-up visits will be scheduled two weeks and three months after baseline visit. Each visit includes dry eye investigations and IOL calculation by IOLmaster 700 and CSO MS-39. After each study visit an IOL will be theoretically selected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years
- •Evidence of meibomian gland dysfunction
- •Meibomian gland secretion score equal or less than 15 (for 15 glands of the lower eye lid) using the meibomian gland evaluator (see below)
排除标准
- •Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
- •Usage of systemic antibiotic therapy
- •Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
- •Ocular surgery within prior 3 months
- •Ocular injury within prior 3 months
- •Ocular herpes of eye or eyelid within prior 3 months
- •Active ocular infection
- •Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
- •Eyelid abnormalities that affect lid function
- •Ocular surface abnormality that may compromise corneal integrity
- •Pregnancy
结局指标
主要结局
Spherical and toric IOL power selected at baseline and at 3 months visit
时间窗: 12 months
The difference between pre- and post-treatment biometrical calculated IOL power will be calculated and compared
次要结局
未报告次要终点
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery