Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
研究概览
简要总结
To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.
详细描述
Forty patients requiring cataract surgery will be randomized to treatment of post-operative inflammation with a single intraoperative dexamethasone injection plus a standard course of topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will be administered at baseline, 1 week and 3 weeks following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing bilateral cataract surgery
排除标准
- •central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye
研究组 & 干预措施
Intracameral dexamethasone 9% + postoperative topical prednisolone acetate
dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively
干预措施: dexamethasone intraocular suspension, 9% (Drug)
Intracameral dexamethasone 9% + postoperative topical prednisolone acetate
dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
postoperative topical prednisolone acetate
topical ophthalmic prednisolone acetate for 3 weeks post-operatively
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
结局指标
主要结局
Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
时间窗: 3 weeks
Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L)
次要结局
未报告次要终点
研究者
Sanjay N Rao, MD
Principal Investigator
SR Cornea Consultants