Establishing a Normative Database in Pediatric Population of the Head-mounted visuALL Field Analyzer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Retinal sensitivity
研究概览
简要总结
The goal of this study is to determine reference values of the VisuALL Field Test in pediatric population. Standard Automatic Perimetry (SAP) is the gold standard test for the evaluation of different diseases of the visual pathway like glaucoma. Its main goal is to measure the differential light sensitivity at several locations in the central field of vision. Nevertheless, the accuracy of the current devices is limited by several factors such as the inherent inconsistency of the psychophysical test, stressful examinations and frequency of testing.
Several devices have been developed since the advent of the Octopus Perimeter and the Humphrey Field Analyzer (HFA) in an effort to improve the early detection of glaucoma. Several of these visual field test variants are implemented using laptops, iPads, and virtual reality headsets. These modalities bring portability but lack fixation methods, environmental control, and hardware standardization. These deficiencies may limit their wide usage.
The main goal of this study is to develop an initial pediatric reference database of a novel visual field test ecosystem that takes advantage of a Head Mounted Device (HMD).
详细描述
This is a cross-sectional observational study. The primary endpoint of the study will be at the end of the recruitment phase.
- Participants that qualify for the study will be invited to a clinical site of the Vanderbilt Eye Institute or equivalent testing space and best corrected visual acuity will be checked with standard Snellen Acuity chart.
- Once vision is confirmed to meet study requirements, the child will be instructed on how to use the headset.
- The test will be generated and participant will complete various testing strategies including suprathreshold, full threshold and individual point testing and possibly other strategies for frequency of seeing curves.
- Patient with pathology may be confirmed with formal standard of care visual field testing
- Short survey will be administered to inquire on ease of device use
- Data will be submitted for analysis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No history of intraocular surgery
- •Best corrected visual acuity (BVCA) 20/25 or better in each eye
排除标准
- •A spherical refraction outside ± 5.0 D and cylinder correction outside 2.0 D.
- •Intraocular surgery in the study eye
- •History of systemic condition known to affect visual function.
- •History of medication known to affect visual function.
结局指标
主要结局
Retinal sensitivity
时间窗: End of the recruitment phase, average 3 months
Retinal sensitivity at each location and compared between the two test strategies
Mean retinal sensitivity
时间窗: End of the recruitment phase, average 3 months
Mean retinal sensitivity at each quadrants and each hemifield
次要结局
- Frequency of seeing curves(End of the recruitment phase, average 3 months)
- Ease of device use(End of the recruitment phase, average 3 months)
研究者
Sylvia L. Groth, MD
Assistant Professor of Ophthalmology
Vanderbilt University Medical Center