NCT06539715已完成4 期
Comparison of Visual Field Assessments Between Three Perimeters
Gainesville Eye Associates2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024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
- 54
- 试验地点
- 2
- 主要终点
- Total acquisition time (both eyes)
研究概览
简要总结
A single center, prospective, randomized, comparative study of visual field assessments between the TEMPO, VisuALL, and HFA perimeters. Subjects will be assessed at 1 visit. Clinical evaluations will include MD, PSD, FT, VFI, OCT, and a questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Adult patients with best-corrected visual outcomes of 20/30 or better.
排除标准
- •Unable to tolerate ophthalmic imaging
- •Any ocular or systemic conditions, that could affect VF test results, such as age-related macular degeneration, peripheral retinal disease, or severe glaucoma.
- •The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
研究组 & 干预措施
TEMPO
Experimental
Visual field assessment with the TEMPO
干预措施: Visual field assessment (Diagnostic Test)
Humphrey Field Analyzer
Active Comparator
Visual field assessment with the Humphrey Field Analyzer
干预措施: Visual field assessment (Diagnostic Test)
VisuALL
Active Comparator
Visual field assessment with the VisuALL
干预措施: Visual field assessment (Diagnostic Test)
结局指标
主要结局
Total acquisition time (both eyes)
时间窗: Visit 1 (Day 0)
Total Acquisition Time (Both Eyes)
时间窗: Visit 1 (Day 0)
The total time to complete automated perimetry in both eyes.
次要结局
- Pattern standard deviation (PSD)(Visit 1 (Day 0))
- Foveal threshold (FT)(Visit 1 (Day 0))
- Mean deviation (MD)(Visit 1 (Day 0))
- Patient questionnaire(Visit 1 (Day 0))
- Mean Deviation (MD)(Visit 1 (Day 0))
- Pattern Standard Deviation (PSD)(Visit 1 (Day 0))
- Foveal Threshold (FT)(Visit 1 (Day 0))
- Patient Questionnaire(Visit 1 (Day 0))
研究者
研究点 (2)
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