A Randomized, Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Conjunction With Cataract Surgery Performed in Combination With Minimally Invasive Glaucoma Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Mean Intraocular Pressure from Baseline
研究概览
简要总结
To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)
详细描述
The purpose of this study is to monitor glaucoma patients intraocular pressure (IOP) after cataract surgery performed in conjunction with minimally invasive glaucoma surgery. After qualifying for this study, subjects will be randomized in a 1:1 allocation of one of two arms. The purpose of this study is to determine if Dextenza (dexamethasone) 0.4mg intracanalicular insert delivery system, provides a decreased risk of elevated post-operative IOP vs. standard therapy controlled topical steroid Durezol (Difluprednate ophthalmic emulsion) 0.05%
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
- None
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
- •Age 18 or Older
- •Mild-to-moderate primary open angle glaucoma and visually significant cataract with plans to undergo clear cornea cataract surgery with Phacoemulsification and implantation of posterior chamber IOL combined with minimally invasive glaucoma surgery ( MIGS) procedure in both eyes.
排除标准
- •Use of Topical steroid, systemic steroid or intravitreal steroid implants within last 3 months
- •Previous Corneal surgery or pathology
- •Active or history of chronic or recurrent inflammatory eye disease in either eye
- •Ocular Pain in either eye
- •Proliferative diabetic retinopathy in either eye
- •Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye.
- •Laser or incisional ocular surgery during the study period and 6 months prior in either eye
- •Systemic concomitant pain medication management with the pharmacology class of Oxycodone
- •Systemic NSAIDS use >/=750 mg daily
- •Clinically significant macular edema
- •History of cystoid macular edema in either eye
研究组 & 干预措施
Dextenza 0.4mg
Intracanalicular insert
干预措施: Dextenza 0.4mg intracanalicular Insert (Drug)
Durezol 0.05%
difluprednate ophthalmic emulsion
干预措施: Durezol 0.05% Ophthalmic Emulsion (Drug)
结局指标
主要结局
Mean Intraocular Pressure from Baseline
时间窗: 30 days - IOP measured at day 1, day 14 and day 30
Sustained tapered release of Dextenza compared to Durezol 4 week taper as measured by mean IOP from baseline.
次要结局
未报告次要终点
研究者
Cathleen McCabe MD
Principal Investigator
The Eye Associates