NCT03511638已完成不适用
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Percent Change in Mean Epithelial Cell Density (ECD)
研究概览
简要总结
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
详细描述
This is a multicenter, controlled, randomized, monocular trial evaluating the safety and effectiveness of the Bausch & Lomb DVisc40 dispersive OVD compared to the Alcon VISCOAT® dispersive OVD when used in cataract surgery. Subjects will be randomized to one of the two treatment groups in a 1:1 ratio (DVisc40:VISCOAT®).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be at least 45 years old and have a clinically documented diagnosis of age-related non-complicated cataract that is considered amenable to treatment with standard phacoemulsification cataract extraction and IOL implantation.
- •The subject must have the capability to provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
- •The subject must be willing and able to return for all scheduled follow-up examinations through 90 days following surgery.
- •Study #877 Protocol DVisc40 28JUL2017 V1.0 CONFIDENTIAL Page 16 of 53
- •The subject must have clear intraocular media other than the cataract in the operative eye.
排除标准
- •The subject has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
- •The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.
- •The subject has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye.
- •The subject has any condition which prevents reliable specular microscopy in the operative eye.
研究组 & 干预措施
Bausch & Lomb DVisc40
Experimental
Ophthalmic viscosurgical device
干预措施: Bausch & Lomb DVisc40 (Device)
Alcon VISCOAT®
Active Comparator
Ophthalmic viscosurgical device
干预措施: Alcon VISCOAT® (Device)
结局指标
主要结局
Percent Change in Mean Epithelial Cell Density (ECD)
时间窗: Day 90
Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg
时间窗: 90 days
次要结局
未报告次要终点
研究者
研究点 (1)
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