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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2600118859 |
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最近更新日期: Date of Last Refreshed on: |
2026-02-11 17:42:36 |
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注册时间: Date of Registration: |
2026-02-11 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
基于居家眼压监测与特殊事件关联的中国青光眼患者眼压波动规律及临床管理研究 (CHGIS研究) |
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Public title: |
A Study on Intraocular Pressure Fluctuation Patterns and Clinical Management in Chinese Glaucoma Patients Based on Home IOP Monitoring and Association with Special Events (CHGIS Study) |
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注册题目简写: |
CHGIS研究 |
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English Acronym: |
CHGIS Study |
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研究课题的正式科学名称: |
基于居家眼压监测与特殊事件关联的中国青光眼患者眼压波动规律及临床管理研究 |
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Scientific title: |
A Study on Intraocular Pressure Fluctuation Patterns and Clinical Management in Chinese Glaucoma Patients Based on Home IOP Monitoring and Association with Special Events |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
刘晓岸 |
研究负责人: |
孙兴怀 |
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Applicant: |
Liu Xiao'an |
Study leader: |
Sun Xinghuai |
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申请注册联系人电话: Applicant telephone: |
+86 21 6538 6885 |
研究负责人电话:
Study leader's |
+86 139 1661 8678 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
499211808@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
xhsun@shmu.edu.cn |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
中国江苏省苏州市工业园区星湖街218号A3楼203单元 |
研究负责人通讯地址: |
中国上海市徐汇区汾阳路83号 |
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Applicant address: |
Unit 203, Building A3, 218 Xinghu Street, Suzhou Industrial Park, Suzhou, Jiangsu,China |
Study leader's address: |
83 Fenyang Road, Xuhui District, Shanghai,China |
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申请注册联系人邮政编码: Applicant postcode: |
215123 |
研究负责人邮政编码: Study leader's postcode: |
200031 |
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申请人所在单位: |
海思盖德(苏州)生物医学科技有限公司 |
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Applicant's institution: |
HSGD Healthguard (Suzhou) Biomedical Technology, Co., Ltd |
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研究负责人所在单位: |
复旦大学附属眼耳鼻喉科医院 |
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Affiliation of the Leader: |
Eye and ENT Hospital Affiliated to Fudan University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
[2025]伦审字第(2025318)号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
复旦大学附属眼耳鼻喉科医院伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Eye & ENT Hospital of Fudan University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-12-19 00:00:00 | ||
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伦理委员会联系人: |
闫晶超 |
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Contact Name of the ethic committee: |
Yan Jingchao |
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伦理委员会联系地址: |
中国上海市徐汇区汾阳路轻科大厦906室 |
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Contact Address of the ethic committee: |
Room 906, Qingke Building, 83 Fenyang Road, Xuhui District, Shanghai,China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 21 3423 2762 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
复旦大学附属眼耳鼻喉科医院 |
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Primary sponsor: |
Eye &ENT Hospital of Fundan University |
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研究实施负责(组长)单位地址: |
中国上海市徐汇区汾阳路83号复旦大学附属眼耳鼻喉科医院青光眼科 |
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Primary sponsor's address: |
83 Fenyang Road, Xuhui District, Shanghai,China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
北京星辰黄斑病公益基金会 |
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Source(s) of funding: |
Beijing Star Macular Disease Foundation |
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研究疾病: |
青光眼 |
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Target disease: |
Glaucoma |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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研究目的: |
1.主要研究目的:构建覆盖全国百家中心、超1000例中国青光眼患者的眼压-事件、眼压-治疗数据库,绘制不同类型青光眼的24小时+周尺度波动标准曲线。 2.次要研究目的:量化6类核心特殊事件与眼压波动的关联强度(点药/压力/失眠/运动/体位/饮水等);提出中国人群专属的高风险事件干预阈值;量化不同治疗方案对眼压波动的控制效果;提出中国人群专属的眼压波动控制目标。 |
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Objectives of Study: |
1.Primary research objective: Build a database covering intraocular pressure, events, and intraocular pressure treatment data of over 1,000 Chinese glaucoma patients from national centers across the country, and map the 24 hour/ weekly rhythm fluctuation standard curves for different types of glaucoma. 2.Secondary research objective: Quantify the association strength between six types of core special events and intraocular pressure fluctuations (medication application/stress/insomnia/exercise/body position/water intake, etc.); Propose the intervention threshold for high-risk events specific to the Chinese population; Quantify the control effects of different treatment regimens on intraocular pressure fluctuations; Propose specific intraocular pressure fluctuation control targets for the Chinese population. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
1. 符合《中国青光眼指南(2020年)》诊断标准(POAG 需满足眼压>=21mmHg 或 NTG 伴视盘/视野异常,闭角型需房角关闭>=180°); 2. 理解居家眼压测量的重要性与必要性,同时接受回弹式家用眼压计的培训; 3. 能自主提供至少1年1次视野检查与1年1次眼底图像采集; 4. 年龄>=18周岁,性别不限; 5. 具备基本的智能手机操作能力,能够熟练使用回弹式眼压计小程序进行数据录入与监测; 6. 自愿参加本研究并签署知情同意书。 |
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Inclusion criteria |
1. Meet the diagnostic criteria in China Glaucoma Guidelines (2020) (for POAG: intraocular pressure >=21mmHg; for NTG: accompanied by optic disc/visual field abnormalities; for angle-closure glaucoma: angle closure >=180°); 2. Understand the importance and necessity of home intraocular pressure measurement, and receive training on the rebound-type home tonometer; 3. Be able to independently provide at least 1 visual field examination and 1 fundus image collection per year; 4. Aged >=18 years, gender not limited; 5. Have basic smartphone operation skills, and be proficient in using the rebound tonometer mini-program for data entry and monitoring; 6. Voluntarily participate in this study and sign the informed consent form. |
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排除标准: |
1. 角膜厚度测量误差>5μm; 2. 眼底图像视盘区域遮挡>10%(如白内障、玻璃体混浊); 3. 回弹式眼压计使用的禁忌症患者(如活动性眼部感染、眼球震颤等); 4. 合并严重心、肝、肾等脏器功能不全,无法完成2年随访者; 5. 精神疾病患者或认知功能障碍者,无法配合完成监测与数据记录; 6. 同时参与其他类似青光眼相关临床研究者。 |
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Exclusion criteria: |
1.Corneal thickness measurement error > 5μm; 2.Optic disc area obstruction in fundus images > 10% (e.g., cataracts, vitreous opacity); 3.Patients with contraindications to the use of rebound tonometers (e.g., active ocular infection, nystagmus, etc.); 4.Complicated with severe cardiac, hepatic, renal or other organ dysfunction, unable to complete 2-year follow-up; 5.Patients with mental illness or cognitive impairment, unable to cooperate with monitoring and data recording; 6.Simultaneously participating in other similar glaucoma-related clinical studies. |
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研究实施时间: Study execute time: |
从 From 2026-02-23 00:00:00至 To 2029-08-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2026-02-23 00:00:00 至 To 2028-09-30 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
不公开/Private |
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盲法: |
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Blinding: |
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是否共享原始数据: IPD sharing |
否No |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
None |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
无 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
None |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |