Phase 3 Study of Brimonidine Tartrate Drops Efficacy in Reducing Post Operative Corneal Edema After Cataract Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- central corneal thickness in micrometer
研究概览
简要总结
Most patients undergoing cataract surgery suffer from corneal edema after the surgery.
Brimonidine drops are a well known and safe Anti-glaucoma medication. the investigators have made several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even if they had normal intra-ocular pressure.
The investigators believe that administering topical Brimonidine to patients with significant post operative corneal edema will hasten the resolution of their corneal edema.
详细描述
Most patients undergoing cataract surgery suffer from corneal edema after the surgery which temporarily reduces their visual acuity until corneal edema resolves over several weeks Brimonidine drops are a well known and safe Anti-glaucoma medication, used to lower intra ocular pressure.
there have been several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even in the presence of normal intra-ocular pressure.
The investigators postulated that administering topical Brimonidine to patients with significant post operative corneal edema will hasten their recovery and visual improvement.
In order to prove that Brimonidine drops contribute to faster resolution of cornel edema and visual improvement, the study will randomly compare 50 post cataract surgery patients (group A)who will be administered Brimonidine to 2 control groups (50 people in each group):
group B will be given topical timolol drops 0.5% (another well recognized anti glaucoma medication which reduces intra-ocular pressure by different mechanism than Brimonidine.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 day after uneventful cataract surgery
- •corneal edema (grade 2 to 3)
排除标准
- •higher than normal intraocular pressure (>23 mm Hg)
- •known sensitivity or contra indication to brimonidine
- •known sensitivity or contra indication to timolol
- •pre operative corneal or anterior segment disease
- •intraoperative complications
- •major ocular pathology other than corneal that reduced vision (retinal degeneration, optic neuropathy etc.)
- •pregnant women
研究组 & 干预措施
brimonidine
50 patients receiving Brimonidine Tartrate drops in the operated eye: 1 drop X2 a day for 1 month.
they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops)
干预措施: Brimonidine Tartrate 0.2% (Drug)
2 tmolol
50 patients receiving timolol maleate 0.5% drops in the operated eye
1 drop X2 a day for 1 month. they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops)
干预措施: Timolol maleate 0.5% (Drug)
结局指标
主要结局
central corneal thickness in micrometer
时间窗: day 0 (day of enrollment ), day 7, day 30
次要结局
- grading of corneal edema (1-3)(day 0 (day of enrollment), day 7, day 30)