Tolerability of an Anesthesia-free Tonometer Tip
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Patient tolerability rating of different tips
研究概览
简要总结
The purpose of this study is to compare the tolerability and comfort of 4 different prototype anesthesia-free tonometer tips with the standard tonometer tip in conjunction with anesthesia. The best-tolerated prototype anesthesia-free tonometer tip will be identified for further development for home tonometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Presenting for a routine eye exam
- •≥ 18 years of age
- •Able and willing to give consent
排除标准
- •History of corneal scarring
- •Active infection of the eye
- •History of alternated corneal sensitivity
- •History of corneal surgery
研究组 & 干预措施
Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm
干预措施: Medical grade silicone of a thickness <100 µm (Diagnostic Test)
Medical grade acrylic tip coated with medical grade silicone of a thickness > 100 µm
干预措施: Medical grade silicone of a thickness >100 µm (Diagnostic Test)
Medical grade acrylic tip coated with medical grade silicone of a thickness < 100 µm with blue tint
干预措施: Medical grade silicone of a thickness <100 µm with blur tint (Diagnostic Test)
Standard tip in conjunction with a topical anesthetic
干预措施: Standard tip in conjunction with a topical anesthetic (Diagnostic Test)
Medical grade acrylic tip covered by a sterile commercially available bandage contact lens
干预措施: Sterile commercially available bandage contact lens (Diagnostic Test)
结局指标
主要结局
Patient tolerability rating of different tips
时间窗: Baseline
Tolerability of the different prototype anesthesia-free tonometer tips with the standard tonometer tip - based on a 0-5 scale the participants reports with higher score meaning more comfortable.
Patient comfort rating of different tips
时间窗: Baseline
Comfort of the different prototype anesthesia-free tonometer tips with the standard tonometer tip - based on a 0-5 scale the participants reports with higher score meaning more comfortable.
Patient tolerability rating of different tips
时间窗: Baseline
Tolerability of the different prototype anesthesia-free tonometer tips with the standard tonometer tip - based on a 0-5 scale the participants reports with higher score meaning more comfortable.
Patient comfort rating of different tips
时间窗: Baseline
Comfort of the different prototype anesthesia-free tonometer tips with the standard tonometer tip - based on a 0-5 scale the participants reports with higher score meaning more comfortable.
次要结局
未报告次要终点