NCT01298973已完成4 期
Dispervise Ophthalmic Viscoelastic as an Agent to Ensure Watertight Wound Closure After Clear Corneal Cataract Incisions
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
- 50
- 试验地点
- 2
- 主要终点
- Ensure watertight, patient wound closure after clear corneal cataract incisions
研究概览
简要总结
The purpose of this study is to look at the ability of Viscoat to ensure proper wound closure.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent, complete questionnaires, and likely to complete all visits
- •Subject must be male or female, of any race, and at least 21 years old
- •Undergoing uncomplicated cataract surgery with clear corneal incisions
排除标准
- •Subjects with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised,etc.)
- •Uncontrolled systemic disease
- •Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
- •Subjects who use concurrent topical or systemic medications that may impair healing, including but not limited to:antimetabolites,isotretinoin (Accutane) within 6 months of treatment, and amiodarone hydrochloride (Cordarone) within 12 months of treatment
- •Subjects with a history of any of the following medical conditions, or any other condition that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid arthritis
- •Concurrent participation or participation in the last 30 days in any other clinical trial
研究组 & 干预措施
Saline
Experimental
One group will receive Saline to irrigate the wound
干预措施: Saline (Drug)
Viscoat
Experimental
One group will receive Viscoat to close the surgical wound
干预措施: Viscoat (Drug)
结局指标
主要结局
Ensure watertight, patient wound closure after clear corneal cataract incisions
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (2)
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