Effect of Chitosan-N-Acetylcysteine (Lacrimera®) on IOL-power Prior to Cataract Surgery: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Difference in spherical and toric IOL power
研究概览
简要总结
Aim of this study is to evaluate the effect of treatment with Lacrimera® on calculated IOL power prior to cataract surgery and on the stability of ocular surface parameters compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).
详细描述
The present study seeks to investigate the effect of treatment with Lacrimera® on the calculated IOL power prior to cataract surgery and on the stability of ocular surface parameters compared to preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
All study-related measurements will be performed by a masked observer.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years
- •Corneal staining (marked to severe; NEI grading scale >=10)
排除标准
- •Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
- •Usage of systemic antibiotic therapy 7
- •Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
- •Ocular surgery within prior 3 months
- •Preceding refractive surgery (e.g. LASIK)
- •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 and nursing women (in women of childbearing age a pregnancy test will be performed before inclusion into the study)
结局指标
主要结局
Difference in spherical and toric IOL power
时间窗: 2 weeks
Difference in spherical and toric IOL power between baseline and the 2 weeks visit
Spherical and toric IOL power
时间窗: 2 weeks
Spherical and toric IOL power selected at the 2 weeks visit
次要结局
- Reproducibility of biometry readings(2 weeks +/- 2 days)
- Difference between study and control eye(2 weeks +/- 2 days)
- Change of dry eye parameters(2 weeks +/- 2 days)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery