NCT00758199已完成4 期
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- OCT with macular thickening
研究概览
简要总结
The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（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 bilateral cataract surgery
- •Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
- •Expected visual outcome of BCVA > [greater than or equal to] 20/30 postoperatively
- •Ability to provide informed consent, take study medications as directed, and likely to complete all study visits
排除标准
- •Known contraindication to any study medication or any of their components
- •Required use of ocular medications other than the study medications during the study
- •Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
- •Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
- •Anticipated need for mechanical iris dilating devices
研究组 & 干预措施
2
Active Comparator
Moxifloxacin
干预措施: Moxifloxacin hydrochloride (Drug)
3
Placebo Comparator
Prednisolone Acetate
干预措施: Prednisolone Acetate (Drug)
1
Active Comparator
Bromfenac
干预措施: Bromfenac (Drug)
结局指标
主要结局
OCT with macular thickening
时间窗: 3-6 weeks
次要结局
- Incidence of CME(3-6 weeks)
研究者
研究点 (1)
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