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使用視網膜圖像分析的方法檢測青少年憂鬱症及焦慮風險的初步研究
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注册号：

Registration number：

 ChiCTR2500104715 

最近更新日期：

Date of Last Refreshed on：

 2025-06-22 23:59:54 

注册时间：

Date of Registration：

 2025-06-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

使用視網膜圖像分析的方法檢測青少年憂鬱症及焦慮風險的初步研究

Public title：

The use of automatic retinal image analysis to detect the risk of anxiety and depression in adolescents

注册题目简写：

English Acronym：

研究课题的正式科学名称：

使用視網膜圖像分析的方法檢測青少年憂鬱症及焦慮風險的初步研究

Scientific title：

The use of automatic retinal image analysis to detect the risk of anxiety and depression in adolescents

研究课题代号(代码)：

Study subject ID：

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：

Maria LAI 

研究负责人：

Prof. Benny Zee 

Applicant：

Maria LAI 

Study leader：

Prof. Benny Zee 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8865

研究负责人电话：

Study leader's
telephone：

+852 2252 8865

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：

 marialai@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 bzee@cuhk.edu.hk

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)：

申请注册联系人通讯地址：

Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

研究负责人通讯地址：

Room 501-2, JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T. Hong Kong

Applicant address：

Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Study leader's address：

Room 501-2, JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T. Hong Kong

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：

申请人所在单位：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2025.024

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：

Clinical Research Ethics Committee of Joint CUHK-NTEC

Name of the ethic committee：

Clinical Research Ethics Committee of Joint CUHK-NTEC

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-25 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, HK

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, HK

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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：

Centre for Clinical Research and Biostatistics, The Chinese University of Hong Kong

Primary sponsor：

Centre for Clinical Research and Biostatistics, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Primary sponsor's address：

Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Centre for Clinical Research and Biostatistics, CUHK

具体地址：

Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T.

Institution
hospital：

Centre for Clinical Research and Biostatistics, CUHK

Address：

Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T.

经费或物资来源：

N/A

Source(s) of funding：

N/A

研究疾病：

Anxiety and Depression  

Target disease：

Anxiety and Depression

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

1. To evaluate if specific characteristics of fundus images are significantly associated with the risk of anxiety and depression compared to healthy adolescents. 2. To explore using fundus retinal images as a screening tool for detecting the risk of anxiety and depression.  

Objectives of Study：

1. To evaluate if specific characteristics of fundus images are significantly associated with the risk of anxiety and depression compared to healthy adolescents. 2. To explore using fundus retinal images as a screening tool for detecting the risk of anxiety and depression.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. Age < 12 Or >17 2. Unwillingness or inability to comply with procedures required in the protocol 3. Poor retinal image quality that cannot be used in the analysis 4. Other eye diseases that are not suitable for retinal imaging include congenital cataracts and retinopathy of prematurity 5. Children are distressed by a flashlight or have experience with photosensitive seizures 6. Written consent not given by the subject's legal guardian/ parent

Exclusion criteria：

1. Age < 12 Or >17 2. Unwillingness or inability to comply with procedures required in the protocol 3. Poor retinal image quality that cannot be used in the analysis 4. Other eye diseases that are not suitable for retinal imaging include congenital cataracts and retinopathy of prematurity 5. Children are distressed by a flashlight or have experience with photosensitive seizures 6. Written consent not given by the subject's legal guardian/ parent

研究实施时间：

Study execute time：

从 From 2025-06-26 00:00:00至 To 2026-12-25 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-26 00:00:00 至 To 2026-06-25 00:00:00

干预措施：

Interventions：

组别：

anxiety/depression subjects

样本量：

 60

Group：

anxiety/depression subjects

Sample size：

干预措施：

N/A

干预措施代码：

 N/A

Intervention：

N/A

Intervention code：

组别：

healthy individuals

样本量：

 540

Group：

healthy individuals

Sample size：

干预措施：

N/A

干预措施代码：

 N/A

Intervention：

N/A

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Evangelical Lutheran Church Social Service 

单位级别：

 N/A 

Institution
hospital：

Evangelical Lutheran Church Social Service

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

retinal vessels parameters

指标类型：

主要指标

Outcome：

retinal vessels parameters

Type：

Primary indicator

测量时间点：

测量方法：

automatic retinal image analysis (ARIA)

Measure time point of outcome：

Measure method：

automatic retinal image analysis (ARIA)

指标中文名：

classification model

指标类型：

次要指标

Outcome：

classification model

Type：

Secondary indicator

测量时间点：

测量方法：

Machine Learning Approach

Measure time point of outcome：

Measure method：

Machine Learning Approach

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 12 岁 years
最大 Max age 17 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

Upon request from Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Beginning 12 months and ending 18 months following article publication.

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

Upon request from Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. Beginning 12 months and ending 18 months following article publication.

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：

Case Report Form

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

Case Report Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-06-22 23:59:48
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