Evaluation of a Novel Head-Mounted Device for Glaucoma Testing: A Proof-of-Concept Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Visual field differential light sensitivity
研究概览
简要总结
This proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. The novel head-mounted device, with custom software, will be compared to a conventional visual field test: The Humphrey Visual Field Analyzer. The investigators will include 30 healthy normal patients, 30 glaucoma suspects, 30 patients with moderate glaucoma, and 30 patients with advanced glaucoma (total: 120 patients). Each patient will perform the conventional test and the head-mounted device visual field test during the study visit, with the order (i.e., which device the patient starts with) being randomized. After the two tests, the patient will fill out a questionnaire to gather information regarding patient comfort and satisfaction. This will repeat each week for 5 weeks, for a total of 5 study visits. The results of the tests (sensitivity thresholds) will be compared. The investigators hypothesize that the results of the conventional and head-mounted device will be similar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Previous visual field test with Humphrey Field Analyzer indicating normal field, early glaucomatous field damage, moderate glaucomatous field damage, or advanced glaucomatous field damage.
- •Ability to understand and consent to the study.
排除标准
- •Diagnosis of secondary glaucoma
- •Diagnosis of non-glaucomatous optic neuropathy or other significant ophthalmic diagnosis that could limit vision (ex. age-related macular degeneration)
- •Significant media opacity
- •Previous intraocular surgery other than cataract surgery
- •Anxiety disorder
- •Pregnancy
- •Seizure disorder
- •Cardiac pacemaker or other implantable devices
- •Severe vertigo or balance disturbance
- •Refractive error greater than +4 diopters and less than -6 diopters spherical equivalent
- •Inability to demonstrate competence to make informed decision regarding study participation
研究组 & 干预措施
Single Arm
Patients will perform visual field testing with the Humphrey Visual Field Analyzer and with the custom head-mounted device.
干预措施: Visual Field Testing (Diagnostic Test)
结局指标
主要结局
Visual field differential light sensitivity
时间窗: 5 weeks
Comparison of differential light sensitivity threshold estimated with the Humphrey Visual Field Analyzer and the custom head-mounted device.
次要结局
- Reproducibility of sensitivity values(5 weeks)
研究者
Brennan Eadie
Assistant Professor, Department of Ophthalmology, Dalhousie University and Nova Scotia Health Authority; MD, PhD, FRCSC
Nova Scotia Health Authority