NCT00698724已完成4 期
A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care
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
- 200
- 试验地点
- 1
- 主要终点
- OCT
研究概览
简要总结
To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female at least 18 years of age.
- •Expectation of 20/25 best corrected visual acuity (BCVA) post-operatively.
- •Patients should be in good general health and devoid of recognized risk factors for CME.
- •Patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy)
- •Patients must be likely to provide informed consent, take study medications as directed, and complete all study visits
- •Only one eye of each treated patient may be included in the study
排除标准
- •Any known contraindications to any study medication or their component
- •Presence of uncontrolled systemic disease
- •Required use of other ocular medications during the study
- •o Artificial tears may be used
- •Diabetics with any clinically evident or history of retinopathy
- •Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation
- •Abnormal pre-operative OCT (if obtainable)
研究组 & 干预措施
1
Active Comparator
Group 1: Xibrom, Optive
干预措施: Xibrom, and Optive (Drug)
2
Active Comparator
Group 2: Xibrom, Pred Forte
干预措施: Xibrom and Pred Forte (Drug)
结局指标
主要结局
OCT
时间窗: 2-4 months
次要结局
- Visual Acuity(2-4 months)
研究者
研究点 (1)
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