An Investigator-Initiated Multicenter Prospective Clinical Trial to Examine the Efficacy of Peri-operative NSAID vs Steroid Treatment in Trabeculectomy Wound Management
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 主要终点
- Target IOP
研究概览
简要总结
This study will examine the efficacy of steroid vs NSAID treatment in relation to trabeculectomy wound management. Eligible study participants will be randomized to receive either steroid or NSAID topical treatment one week post-trabeculectomy. Each group will dose with their assigned study treatment until three months post-trabeculectomy. Study participants will be followed for twelve months post-trabeculectomy.
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
- •Adult patients over the age of 18 years
- •Uncontrolled open angle glaucoma
- •Scheduled to undergo stand-alone trabeculectomy
- •No previous incisional glaucoma surgery
- •No ocular surgery of any kind in prior 6 months
排除标准
- •steroids and/or NSAIDs contraindicated
- •poor corneal epithelial health
研究组 & 干预措施
NSAID
Bromfenac 0.07% Oph Susp: used from one week post-op to three months post-op
干预措施: Bromfenac 0.07% Oph Susp (Drug)
Steroid
Dexamethasone: used from one week post-op to three months post-op
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Target IOP
时间窗: 12 months
the proportion of patients achieving a target IOP range (≤21, ≤18, ≤15 or ≤12 mmHg) at 12 months post-operatively
次要结局
未报告次要终点
研究者
Cindy Hutnik
Principal Investigator
Ivey Eye Institute