NCT05792046已完成不适用
IMOvifa Perimeter Reference Database
New View Optometric Center4 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2023年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 376
- 试验地点
- 4
- 主要终点
- Reference limit for mean deviation
研究概览
简要总结
This study will collect data to establish a reference database for the IMOvifa perimeter.
详细描述
This study will collect data from a reference population to be used as inputs to the calculation of age corrected significance limits for expected visual function sensitivity to establish reference limits for key output parameters for select test patterns of the IMOvifa perimeter device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •22 years of age or older on the date of informed consent
- •Able to understand the written informed consent and willing to participate
- •IOP ≤ 21 mmHg (each eye)
- •BCVA 20/40 or better (each eye)
- •Both eyes free of ocular conditions that may affect visual function (at doctor's discretion)
排除标准
- •Unable to tolerate ophthalmic imaging and/or VF testing
- •History of conditions known to adversely affect visual function (at doctor discretion)
- •Spherical Equivalent refractive error outside the range from +6 Diopters
- •Cylindrical refractive error outside the range +2.5 Diopters
结局指标
主要结局
Reference limit for mean deviation
时间窗: Day 1
Visual sensitivity level in decibels
次要结局
未报告次要终点
研究者
研究点 (4)
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