NCT00469781已完成4 期
Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening
Center For Excellence In Eye Care1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Cystoid Macular Edema
研究概览
简要总结
The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.
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 (Investigator)
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
- •· Male or female > 18 years of age scheduled to undergo cataract surgery
- •Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
- •Expected visual outcome of 20/25 or better.
- •Ability to provide informed consent and likely to complete all study visits
排除标准
- •· Known contraindication to any study medication or any of their components
- •Uncontrolled systemic disease
- •Required use of ocular medications other than the study medications during the study
- •Abnormal pre-operative OCTs
- •Diabetic patients with a history of macular edema or diabetic retinopathy
- •AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease
- •Only one eye of each patient can be enrolled
研究组 & 干预措施
1
Active Comparator
干预措施: 1. Pred Forte (Drug)
2
Other
干预措施: 2. Xibrom (Bromfenac) (Drug)
结局指标
主要结局
Cystoid Macular Edema
时间窗: 11 months
次要结局
- Retinal Thickening(11 months)
研究者
研究点 (1)
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