NCT04208750已完成4 期
Clinical Investigation of the Vision-R800 Device. Understanding the Value of High Precision Refractions and Lenses to Optometrists and Patients. Phase 2
Pete Kollbaum, OD, PhD1 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2019年11月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Subjective Questionnaire Response
研究概览
简要总结
Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and associated spectacle lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •current adaptated progressive addition lens wearer, if bifocal lens required
- •wearable pair of glasses < 2 years old
- •wear glasses at least 6 hours per day
排除标准
- •Eye Disease with an impact on visual acuity or binocular vision abnormalities (by self-report)
- •Formal training in optometry, vision science or in the eyecare field
研究组 & 干预措施
S-Refraction
Active Comparator
干预措施: Standard Phoropter (Device)
S-Refraction
Active Comparator
干预措施: Vision R-800 Phoropter (Device)
R-Refraction
Experimental
干预措施: Standard Phoropter (Device)
R-Refraction
Experimental
干预措施: Vision R-800 Phoropter (Device)
结局指标
主要结局
Subjective Questionnaire Response
时间窗: at Visit 5 (final visit), up to 5 weeks
Patient questions of refraction preference for quickness, efficiency, comfort, and stress
次要结局
未报告次要终点
研究者
Pete Kollbaum, OD, PhD
Associate Professor, Associate Dean for Research, and Director of the Borish Center for Ophthalmic Research
Indiana University
研究点 (1)
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