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Construction of Eye-feature Model based on Eye Segment Analysis Devices in Healthy People with Different Constitution of Traditional Chinese Medicine

注册号：

Registration number：

ITMCTR2100005372

最近更新日期：

Date of Last Refreshed on：

2021-12-04

注册时间：

Date of Registration：

2021-12-04

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于白睛无影照相机在不同中医体质健康人群的眼象特征模型构建研究

Public title：

Construction of Eye-feature Model based on Eye Segment Analysis Devices in Healthy People with Different Constitution of Traditional Chinese Medicine

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于白睛无影照相机在不同中医体质健康人群的眼象特征模型构建研究

Scientific title：

Construction of Eye-feature Model based on Eye Segment Analysis Devices in Healthy People with Different Constitution of Traditional Chinese Medicine

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

101011

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：

ChiCTR2100053955 ; ChiMCTR2100005372

申请注册联系人：

杨月嫦

研究负责人：

杨月嫦

Applicant：

YANG YUECHANG

Study leader：

YANG YUECHANG

申请注册联系人电话：

Applicant telephone：

18916025825

研究负责人电话：

Study leader's telephone：

18016092419

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

13641639949@163.com

研究负责人电子邮件：

Study leader's E-mail：

13641639949@163.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

上海市虹口区甘河路110号3号楼3楼体检中心

研究负责人通讯地址：

上海市中医药大学附属岳阳中西医结合医院治未病中心

Applicant address：

Physical examination center, 3rd floor, Building 3, No. 110 Ganhe Road, Hongkou District, Shanghai,200083

Study leader's address：

Preventive treatment center, Yueyang integrated Traditional Chinese and Western Medicine Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine,200083

申请注册联系人邮政编码：

Applicant postcode：

200083

研究负责人邮政编码：

Study leader's postcode：

200083

申请人所在单位：

上海市中医药大学附属岳阳中西医结合医院

Applicant's institution：

Yueyang integrated Traditional Chinese and Western Medicine Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2022-017

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

上海市中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2022/1/31 0:00:00

伦理委员会联系人：

殷从全

Contact Name of the ethic committee：

Yin Congquan

伦理委员会联系地址：

上海市虹口区甘河路110号

Contact Address of the ethic committee：

110, Ganhe Road, Hongkou District, Shanghai, China

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：

上海市中医药大学附属岳阳中西医结合医院

Primary sponsor：

Yueyang integrated Traditional Chinese and Western Medicine Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市中医药大学附属岳阳中西医结合医院

Primary sponsor's address：

Yueyang integrated Traditional Chinese and Western Medicine Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine,200083

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

虹口区

Country：

China

Province：

Shanghai

City：

Hongkou District

单位(医院)：

上海市中医药大学附属岳阳中西医结合医院

具体地址：

上海市虹口区甘河路110号

Institution
hospital：

Yueyang integrated Traditional Chinese and Western Medicine Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine

Address：

No. 110 Ganhe Road, Hongkou District, Shanghai,200083

经费或物资来源：

上海中医药大学附属岳阳中西医结合医院院级基金

Source(s) of funding：

Hospital level fund of Yueyang integrated traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of traditional Chinese Medicine

研究疾病：

健康人群

研究疾病代码：

Target disease：

Healthy People

Target disease code：

研究类型：

Study type：

观察性研究

Observational study

研究设计：

Study design：

析因分组（即根据危险因素或暴露因素分组）

Factorial

研究所处阶段：

Study phase：

其它

Others

研究目的：

中医目诊为祖国医学重要组成部分，是基于中医藏象学说。白睛无影照相机依据传统中医目诊理论和现代西医球结膜微循环学说，采用人工智能技术和无影成像光学技术，对眼象进行高清采集、特征提取和综合分析辅助诊断。本研究探讨不同中医体质的健康人群基于白睛无影照相机收集眼象特征构建模型，通过观察外在眼目变化揣测内部脏腑经络等变化，此即谓“司外揣内”，为临床中医辨病辨证的基础理论提供新思路，亦提升“治未病”内涵。

Objectives of Study：

Eye diagnosis is an important part of Traditional Chinese Medicine （TCM）, which is based on Zang Xiang theory of TCM. Eye Segment Analysis Devices, based on both eye-diagnosis theory of TCM and bulbar conjunctival microcirculation theory of Modern Western Medicine, integrate artificial intelligence (AI) and optical shadowless imaging to carry out high-definition acquisition, feature extraction and intelligent analysis of eye-segment feature to assist diagnosis. In this study, we collect data of different constitution of TCM in healthy people and construct a diagnosis model of eye-feature imaging collected by Eye Segment Analysis Devices. Obtaining imbalance of the viscera by observing the changes of eyes, which is called "Si Wai Chuai Nei", is not only provides new ideas for the basic theory of disease differentiation and syndrome differentiation in clinical practice of TCM, but also improves the connotation of "preventive treatment of disease" of TCM.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

1 年龄18-80岁、无慢性疾病史、近1年内体检无重大器质性病变； 2 亚健康状态自评量表（SRSHS）总分30-39分，提示处于较完满状态； 3 自愿参加、签署知情同意书

Inclusion criteria

1 Aged between 18 and 80no history of chronic diseases and no major organic lesions were found in general physical examination in recent 1 year 2 The total score of sub-health self rating scale (srshs) is 30-39, indicating that it is in a relatively complete state 3 voluntarily participated in the trial and signed informed consent

排除标准：

1 近1-2周内有过急性病，如感冒、发热、腹泻、大量出血、熬夜、眼部感染 2 检查前全身用力、情绪波动明显、用力揉眼、眼部进异物、眼部碰撞等原因导致眼部不适 3 情绪波动较大 4 上下眼睑打开无法配合

Exclusion criteria：

1 Over acute diseases such as cold, fever, diarrhea, massive bleeding, staying up late and eye infection in recent 1-2 weeks 2 Before the examination, the whole body exertion, obvious mood fluctuation, eye rubbing, foreign body entering the eye, eye collision and other reasons lead to eyes discomfort 3 Emotional instability 4 Unable to cooperate with the opening of the upper and lower eyelids

研究实施时间：

Study execute time：

从From 2021-12-01

至To      2023-10-31

征募观察对象时间：

Recruiting time：

从From 2022-01-01

至To      2023-06-30

干预措施：

Interventions：

组别：

健康人群

样本量：

1000

Group：

healthy group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

1组

样本量：

2000

Group：

one group

Sample size：

干预措施：

眼象采集

干预措施代码：

Intervention：

Eye image collection

Intervention code：

样本总量 Total sample size ： 1000

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海市中医药大学附属岳阳中西医结合医院

单位级别：

三级甲等

Institution/hospital：

Yueyang integrated Traditional Chinese and Western Medicine Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

眼象特征

指标类型：

主要指标

Outcome：

eye-features

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 80 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无，横断面调查研究

Randomization Procedure (please state who generates the random number sequence and by what method)：

N/A，crosssectional study

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

是

Yes

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）：

NA

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NA

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：

NA

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

NA

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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