NCT06135727终止不适用
Data Collection for Development of Topcon Health Score
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- RNFL and GCL thickness
研究概览
简要总结
The objective of this study is to collect data for the development and validation a screening process using aggregate data.
In this study, data collection will encompass both retrospective and prospective approaches across multiple sites in the United States.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Subjects 22 years of age or older on the date of data collection (retrospective) or informed consent (prospective).
- •For prospective data collection or missing retrospective data collection, subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
- •BCVA 20/40 or better (each eye).
- •Normal eyes to have normal ocular examination in both eyes
- •Normal eyes to have IOP ≤ 21 mmHg in both eyes
- •Pathology eyes to have clinical diagnosis of mild or moderate glaucoma in at least one eye
排除标准
- •For prospective or missing retrospective data collection, subjects unable to tolerate ophthalmic testing.
- •Concomitant diseases known to affect the visual field: history of leukemia, dementia, Parkinson's disease, Alzheimer's disease, stroke, or autoimmune diseases.
- •History of intraocular surgery (uncomplicated cataract or glaucoma surgeries are accepted)
- •Ocular findings or history of co-morbidities, including, but not limited to: uveitis, non-glaucomatous optic neuropathy, trauma, retinal detachment, vein or artery occlusions, wet age-related macular degeneration, geographic atrophy, proliferative diabetic retinopathy, vitreous hemorrhage, severe cataract, severe non-proliferative diabetic retinopathy. Controlled diabetes and hypertension participants can be included.
- •Unreliable VF testing and/or poor-quality OCT scans.
- •Poor fixation.
- •Pathology eyes with severe glaucoma
- •Pathology eyes with glaucoma suspect diagnosis
- •Pathology eyes with Ocular Hypertensive diagnosis
结局指标
主要结局
RNFL and GCL thickness
时间窗: 1 day
Using Maestro2 OCT
次要结局
未报告次要终点
研究者
研究点 (1)
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