NCT05529966已完成不适用
Comparing NGENUITY vs Conventional Microscope in a New Hydrus User
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
- 32
- 试验地点
- 1
- 主要终点
- Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out
研究概览
简要总结
To compare the potential efficiency and educational value of using NGENUITY (3D camera system, FDA approved for this indication) vs the conventional microscope for Hydrus microstent placement by new users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Patients with mild to moderate primary open angle glaucoma as defined by AGS with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus microstent
- •Either eye or both eyes may participate
排除标准
- •Lack of patient cooperation severely affecting ability to place stent with any visualization technique
- •Angle abnormalities including PAS in nasal quadrant
- •Unable to properly visualize the angle due to complicated cataract surgery
研究组 & 干预措施
NGENUITY
Experimental
Research fellow participants utilize NGENUITY during micro-stent placement
干预措施: NGENUITY (Device)
Conventional microscope
Active Comparator
Research fellow participants utilize conventional microscope during micro-stent placement
干预措施: Conventional microscope (Device)
结局指标
主要结局
Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out
时间窗: up to 1 hour
次要结局
- Number of Microscope Focus or Position Readjustments Needed During Stent Placement(up to 1 hour)
- Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent(up to 1 hour)
- Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement(up to 1 hour)
- Change in Attending Questionnaire Score(Up to 5 minutes)
- Change in Fellow Questionnaire Score(Up to 5 minutes)
研究者
Robert T. Chang, MD
Associate Professor of Ophthalmology
Stanford University
研究点 (1)
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