Protection of Corneal Epithelium Using Chitosan-N-acetylcysteine Eye Drops During and/or After Cataract Surgery: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Difference in National Eye Institute Grading Scale (NEI Score)
研究概览
简要总结
The aim of this study is to assess if treatment with Lacrimera® eye drops (Croma-Pharma GbmH, Leobendorf, Austria) during and/ or after cataract surgery has a positive effect on the ocular surface compared to control group.
详细描述
Prior to surgery, pre-assessment measurements will be performed in the same fashion as for non-study patients. Patients will be randomized to one of the 3 groups in a 1:1:1 fashion using an online randomization tool (www.randomizer.org, list randomizer).
Surgery is performed in topical anaesthesia. Right after topical anaesthesia, patients allocated to Group 3 will receive 1 drop of Lacrimera® in the study eye. Injection of viscoelastic substance (OVD), capsulorhexis, phacoemulsification, and coaxial irrigation/ aspiration of cortical material are performed as standard procedure. After IOL implantation the OVD will be removed and at the end of the surgery, stromal hydration will be performed to the incision as a routine procedure to seal the wound. Right after the wound is sealed, patients allocated to group 2 and group 3 will receive 1 drop of Lacrimera® in the study eye. Postoperative standard medication (Bromfenac gtt., twice a day for 4 weeks) will be prescribed for all groups.
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
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 or older
- •Scheduled for cataract surgery
- •Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- •Written informed consent prior to surgery
排除标准
- •Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS), cornea pathology (e.g. corneal scars, etc.)
- •Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
- •Previous ocular surgery or trauma in the study eye within 6 months of the cataract surgery
- •Active ocular infection or inflammation
- •Pregnancy (pregnancy test will be taken in women of reproductive age)
- •Subjects with surgery longer than 30 minutes will be excluded and replaced
研究组 & 干预措施
Group 1
15 patients will be included in group 1 (no additional treatment)
Group 2
15 patients will be in group 2 (treatment directly after cataract surgery in the surgical theatre)
干预措施: Lacrimera (Device)
Group 3
15 patients will receive treatment after local anaesthesia (pre-operatively) and directly after cataract surgery (group 3)
干预措施: Lacrimera (Device)
结局指标
主要结局
Difference in National Eye Institute Grading Scale (NEI Score)
时间窗: Day 0
Difference in National Eye Institute Grading Scale (NEI Score) between baseline and 1 hour post cataract surgery
次要结局
- Difference in break-up time and non-invasive break-up time between baseline and 1 week post-operatively in the different groups(7 days +/- 1 day)
- Difference in break-up time and non-invasive break-up time between the groups at all visits(7 days +/- 1 day)
- Subjective complaints using OSDI score(7 days +/- 1 day)
- Difference in number of MMP-9 positive eyes(7 days +/- 1 day)
- Subjective complaints using VAS(7 days +/- 1 day)
- Difference in NEI Score between the groups at all visits(7 days +/- 1 day)
- Difference in NEI Score between all visits post-operatively in the different groups(7 days +/- 1 day)
研究者
Prim. Prof. Dr. Oliver Findl, MBA
Principal Investigator
Vienna Institute for Research in Ocular Surgery