中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500108659
最近更新日期： Date of Last Refreshed on：	2025-09-03 10:01:25
注册时间： Date of Registration：	2025-09-03 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來評估狗主人的認知健康風險的初步研究
Public title：	A pilot study using retinal image analysis to assess cognitive health risk of dog owners
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來評估狗主人的認知健康風險的初步研究
Scientific title：	A pilot study using retinal image analysis to assess cognitive health risk of dog owners
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. ZEE Chung-ying, Benny
Applicant：	Maria LAI	Study leader：	Prof. ZEE Chung-ying, Benny
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	研究负责人通讯地址：	Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital,Shatin
Applicant address：	Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital,Shatin	Study leader's address：	Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital,Shatin
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：	2023.482	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：	Joint CUHK-NTEC Clinical Research Ethics Committee
Name of the ethic committee：	Joint CUHK-NTEC Clinical Research Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2023-10-17 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, The Chinese University of Hong Kong	具体地址：	Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital,Shatin, N.T., Hong Kong, China
Institution hospital：	Centre for Clinical Research and Biostatistics, The Chinese University of Hong Kong	Address：	Rm 501-502, JC School of Public Health and Primary Care, Prince of Wales Hospital,Shatin, N.T., Hong Kong, China

经费或物资来源：

N/A

Source(s) of funding：

N/A

研究疾病：

Cognitive health risk

Target disease：

Cognitive health risk

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional 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 compare the cognitive health risk of dog owners versus non dog owners using ARIA 2. To explore the feasibility of using handheld fundus cameras in dogs

Objectives of Study：

1. To compare the cognitive health risk of dog owners versus non dog owners using ARIA 2. To explore the feasibility of using handheld fundus cameras in dogs

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：

• Poor retinal images quality that cannot be used in the analysis • Subjects with other eye diseases are unsuitable for retinal imaging, such as severe cataracts, glaucoma, atretopsia, and corneal plague. • Subjects are distressed with a flashlight or have experience with photosensitive seizures. • Unwillingness or inability to comply with procedures required in the protocol

Exclusion criteria：

• Poor retinal images quality that cannot be used in the analysis • Subjects with other eye diseases are unsuitable for retinal imaging, such as severe cataracts, glaucoma, atretopsia, and corneal plague. • Subjects are distressed with a flashlight or have experience with photosensitive seizures. • Unwillingness or inability to comply with procedures required in the protocol

研究实施时间：

Study execute time：

从 From 2024-12-20 00:00:00至 To 2027-03-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-09-15 00:00:00 至 To 2026-09-30 00:00:00

干预措施：

Interventions：

组别：	Dog owner	样本量：	60
Group：	Dog owner	Sample size：	60
干预措施：	N/A	干预措施代码：
Intervention：	N/A	Intervention code：

组别：	Non Dog owner	样本量：	60
Group：	Non Dog owner	Sample size：	60
干预措施：	N/A	干预措施代码：
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)：	Community centers and veterinary clinics	单位级别：	N/A
Institution hospital：	Community centers and veterinary clinics	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：
Measure time point of outcome：		Measure method：

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	18	岁 years
最大 Max age	N/A	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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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
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
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：	2025-09-03 10:01:06