Matching Glaucoma With Impaired Cognition
赞助:
Sun Yat-sen University
合作者:
信息的提供 (责任方):
xiulan zhang，Zhongshan Ophthalmic Center, Sun Yat-sen University
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 2, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | October 8, 2018 | ||
| 预计主要完成日期 | September 30, 2024 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Morbidity of primary open-angle glaucoma[ Time Frame: From October 2018 to September 2024 ] |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Matching Glaucoma With Impaired Cognition | ||
| 正式标题 ICMJE | Association of Glaucoma Morbidity and Impairment of Topological Perception: a Cohort Study | ||
| 简要概况 | Glaucoma is the leading cause of irreversible blindness in the world. The current study is designed to find the underlying relationship between impairment of topological perception and incidence of glaucoma. |
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| 详细说明 | Glaucoma is currently the leading cause of irreversible blindness in the world. It has been a difficult task for ophthalmologists and researchers to diagnose glaucoma, especially in early stage. At present, glaucoma diagnosis mainly relies on OCT and visual field test, which have relatively low sensitivity and specificity at the early stage of glaucoma. Previous studies mainly focused on ocular manifestation of glaucoma. However, there was evidence that abnormalities of visual pathway also existed in patients with glaucoma, indicating cerebral cognitive defects may also be involved in glaucoma development. Thus, we design a cohort study, in which subjects at high-risk of developing glaucoma are separated into two group based on test results of topological perception. After five years' follow-up, morbidity of primary open-angle glaucoma would be compared between groups to see if there was any relationship between impaired cognitive function and incidence of glaucoma. | ||
| 研究类型 ICMJE | Observational | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
3000 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | March 31, 2025 | ||
| 预计主要完成日期 | September 30, 2024 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Aged between 18-55; 2. Best corrected visual acuity ≥ 0.6, capable of completing routine glaucoma examinations; 3. Spherical equivalent < 3D； 4. No history of other ocular diseases (except mild cataract), including diabetic retinopathy, age-related macular degeneration, optical neuropathy, eye trauma, strabismus, nystagmus, severe dry eye, ptosis of the eyelid, etc. Exclusion Criteria: 1. Unable or unwilling to sign informed consent, or cannot comply with the study protocol 2. Diagnosed with any kind of glaucoma (based on visual field and OCT, etc) or primary angle-closure diseases(primary angle closure suspect and primary angle closure, based on gonioscopy and UBM examination); 3. History of ocular surgeries or laser; 4. Diagnosed with specific neurologic diseases or psychiatric disorders: Parkinson's disease, Alzheimer's disease, anxiety, depression, schizophrenia, etc.(based on scale screening) 5. With severe systemic diseases: diabetes mellitus, hypertension(systolic pressure≥160mmHg or diastolic pressure≥100mmHg ), heart diseases, kidney diseases, rheumatological disorder, digestive diseases, cancer, etc. 6. Pregnancy or lactation | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：55 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | China | ||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | xiulan zhang，Zhongshan Ophthalmic Center, Sun Yat-sen University | ||
| 研究赞助商 ICMJE | Sun Yat-sen University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Zhongshan Ophthalmic Center, Sun Yat-sen University | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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