注册号: Registration number: |
ChiCTR1900025243 |
最近更新日期: Date of Last Refreshed on: |
2019-08-17 |
注册时间: Date of Registration: |
2019-08-17 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
过矫负镜联合棱镜治疗间歇性外斜视的作用评估 |
Public title: |
Evaluating effectiveness of overminus combined with prism lenses in Children with intermittent exotropia |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
间歇性外斜视的保守治疗 |
Scientific title: |
Conservative treatment of intermittent exotropia |
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: |
申请注册联系人: |
冯月兰 |
研究负责人: |
李宁东 |
Applicant: |
Yuelan Feng |
Study leader: |
Ningdong Li |
申请注册联系人电话: Applicant telephone: |
+86 15044973994 |
研究负责人电话: Study leader's telephone: |
+86 13621083618 |
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: |
fyl-2006-ky@163.com |
研究负责人电子邮件: Study leader's E-mail: |
lnd30@163.com |
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: |
北京市西城区南礼士路56号 |
研究负责人通讯地址: |
北京市西城区南礼士路56号 |
Applicant address: |
56 South Lishi Road, Xicheng District, Beijing, China |
Study leader's address: |
56 South Lishi Road, Xicheng District, Beijing, China |
申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
首都医科大学附属北京儿童医院 |
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Applicant's institution: |
Beijing Children's Hospital, Capital Medical University |
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: |
2019-k-225 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
批准本研究的伦理委员会名称: |
首都医科大学附属北京儿童医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee of Beijing Children's Hospital Affiliated to Capital Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2019-06-18 | ||
伦理委员会联系人: |
李志刚 |
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Contact Name of the ethic committee: |
Zhigang Li |
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伦理委员会联系地址: |
北京市西城区南礼士路56号 |
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Contact Address of the ethic committee: |
56 South Lishi Road, Xicheng District, Beijing, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
研究实施负责(组长)单位: |
首都医科大学附属北京儿童医院 |
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Primary sponsor: |
Beijing Children's Hospital, Capital Medical University |
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研究实施负责(组长)单位地址: |
北京市西城区南礼士路56号 |
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Primary sponsor's address: |
56 South Lishi Road, Xicheng District, Beijing, 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: |
国家自然科学基金 |
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Source(s) of funding: |
National Natural Science Foundation of China |
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研究疾病: |
间歇性外斜视 |
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Target disease: |
intermittent exotropia |
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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: |
治疗新技术临床试验 | ||||||||||||||||||||||
Study phase: |
New Treatment Measure Clinical Study |
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研究目的: |
评价过矫负镜联合棱镜治疗间歇性外斜视的疗效 |
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Objectives of Study: |
To evaluate the effectiveness of overminus combined with prism spectacles as a primary treatment option for childhood with Intermittent Exotropia |
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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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研究设计: |
单臂 |
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Study design: |
Single arm |
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纳入标准: |
3-7岁间歇性外斜视患儿; 交替遮盖看远斜视度大于15棱镜度; 看近的斜视度不大于看远10个棱镜度 |
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Inclusion criteria |
1. Children aged 3 to <7 years with previously untreated IXT; 2. distance exodeviation at least 15 prism diopters (PD) measured by prism and alternate cover test (PACT); 3. near deviation not exceeding the distance deviation by > 10 PD by PACT. |
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排除标准: |
眼部和神经系统疾病; 大于2D的屈光参差; 除间歇性外斜伴有大于5个棱镜度的垂直斜视; 其他眼部疾病导致的眼位偏斜; 以前做过斜视手术或有A/V型斜视 |
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Exclusion criteria: |
1. children with any neurological or ocular pathology; 2. >2D of anisometropia or >5PD of vertical deviation in addition to the IXT; 3. any other ophthalmological problem leading to specific ocular deviation, or had prior ocular muscle surgery or significant A or V patterns. |
研究实施时间: Study execute time: |
从From2019-09-01至To 2020-09-01 |
征募观察对象时间: Recruiting time: |
从From2019-09-01至To 2020-09-01 |
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): |
N/A |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
N/A |
盲法: |
N/A |
Blinding: |
N/A |
原始数据公开时间: The time of sharing IPD: |
试验完成后6个月内公开/Within six months after the trial complete |
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): |
2021.01.01 |
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
2021.01.01 |
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: |
病例记录表 |
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Case Record Form |
数据管理委员会: Data Managemen Committee: |
暂未确定/Not yet |