ChiCTR2500096375 版本V1.0 版本创建时间2025/01/22 15:28:16 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500096375 

最近更新日期：

Date of Last Refreshed on：

2025-01-22 15:27:58 

注册时间：

Date of Registration：

2025-01-22 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail

Public title：

Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail

Scientific title：

Diagnostic Efficacy and Cost-effectiveness of Artificial Intelligence Systems in Diabetic Retinopathy Screening in Low-Resource Settings: A Multicenter Randomized Controlled Trail

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：

Ms Jennifer Tsoi 

研究负责人：

Dr CHEUNG Yim Lui Carol/Dr NGUYEN Thanh Triet 

Applicant：

Ms Jennifer Tsoi 

Study leader：

Dr CHEUNG Yim Lui Carol/Dr NGUYEN Thanh Triet 

申请注册联系人电话：

Applicant telephone：

+852 3943 5818

研究负责人电话：

Study leader's telephone：

+852 3943 5831

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：

jennifertsoi@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

carolcheung@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：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

研究负责人通讯地址：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

Applicant address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

Study leader's address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

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：

Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong

Applicant's institution：

Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong

研究负责人所在单位：

Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong

Affiliation of the Leader：

Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

654/VSR-GCN

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：

Ministry of Health - Institute of Malaria, Parasitology and Entomology QUY NHON

Name of the ethic committee：

Ministry of Health - Institute of Malaria, Parasitology and Entomology QUY NHON

伦理委员会批准日期：

Date of approved by ethic committee：

2024-09-16 00:00:00

伦理委员会联系人：

Dr Ho Van Hoang

Contact Name of the ethic committee：

Dr Ho Van Hoang

伦理委员会联系地址：

611B Nguyen Thai Hoc street, Binh Dinh Institute of Malariology - Parasitology – Entomology, Quy Nhon City, Binh Dinh Province

Contact Address of the ethic committee：

611B Nguyen Thai Hoc street, Binh Dinh Institute of Malariology - Parasitology – Entomology, Quy Nhon City, Binh Dinh Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+84 256 3847 725

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：

Binh Dinh Eye Hospital

Primary sponsor：

Binh Dinh Eye Hospital

研究实施负责（组长）单位地址：

78 Tran Hung Dao street, Quy Nhon city, Binh Dinh province, Vietnam

Primary sponsor's address：

78 Tran Hung Dao street, Quy Nhon city, Binh Dinh province, Vietnam

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Hong Kong

省(直辖市)：

Hong Kong

市(区县)：

Country：

Hong Kong

Province：

Hong Kong

City：

单位(医院)：

Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong

具体地址：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

Institution
hospital：

Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong

Address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon

经费或物资来源：

Departmental fund

Source(s) of funding：

Departmental fund

Target disease：

Diabetic retinal disease

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 诊断试验新技术临床试验 

Study phase：

Diagnostic New Technique Clincal Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To evaluate the effectiveness, cost-efficiency, and performance of an AI system in detecting VTDR and DME through FP and OCT in a screening unit.  

Objectives of Study：

To evaluate the effectiveness, cost-efficiency, and performance of an AI system in detecting VTDR and DME through FP and OCT in a screening unit.

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) Individuals diagnosed with diabetes mellitus 2) Age 18 years or older

Inclusion criteria

1) Individuals diagnosed with diabetes mellitus 2) Age 18 years or older

排除标准：

1) Individuals with other ocular diseases that are sight-threatening and require urgent treatment, such as wet age-related macular degeneration, retinal detachment, vitreo-macular traction, foveoschisis, retinal vein occlusion, retinal artery occlusion 2) Individuals who refuse or are unable to provide informed consent

Exclusion criteria：

1) Individuals with other ocular diseases that are sight-threatening and require urgent treatment, such as wet age-related macular degeneration, retinal detachment, vitreo-macular traction, foveoschisis, retinal vein occlusion, retinal artery occlusion 2) Individuals who refuse or are unable to provide informed consent

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2025-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-12-10 00:00:00 至 To 2025-02-28 00:00:00  

干预措施：

Interventions：

组别：

Intervention Group 1 (AI-FP)

样本量：

354

Group：

Intervention Group 1 (AI-FP)

Sample size：

干预措施：

Participants will undergo fundus photography. The AI-FP will analyze the FPs to detect referable DR and suspected DME. Referral decisions will be based on the AI-FP findings

干预措施代码：

Intervention：

Participants will undergo fundus photography. The AI-FP will analyze the FPs to detect referable DR and suspected DME. Referral decisions will be based on the AI-FP findings

Intervention code：

组别：

Intervention Group 2 ( AI-FP and AI-OCT)

样本量：

354

Group：

Intervention Group 2 ( AI-FP and AI-OCT)

Sample size：

干预措施：

Participants will undergo fundus photography and OCT imaging. The same AI-FP system used in Intervention Group 1 will analyze the FPs to detect referable DR and suspected DME. The AI-OCT system will analyze the OCT images to detect and classify DME. Referral decisions will be based on the combined findings from AI-FP and AI-OCT.

干预措施代码：

Intervention：

Participants will undergo fundus photography and OCT imaging. The same AI-FP system used in Intervention Group 1 will analyze the FPs to detect referable DR and suspected DME. The AI-OCT system will analyze the OCT images to detect and classify DME. Referral decisions will be based on the combined findings from AI-FP and AI-OCT.

Intervention code：

组别：

Control Group (Standard Screening)

样本量：

354

Group：

Control Group (Standard Screening)

Sample size：

干预措施：

DR screening using FPs without AI assistance.

干预措施代码：

Intervention：

DR screening using FPs without AI assistance.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Vietnam

省(直辖市)：

 Binh Dinh 

市(区县)：

  

Country：

Vietnam 

Province：

Binh Dinh 

City：

 

单位(医院)：

Binh Dinh Eye Hospital 

单位级别：

Provincial 

Institution
hospital：

Binh Dinh Eye Hospital

Level of the institution：

Provincial

国家：

 Vietnam

省(直辖市)：

 Binh Dinh 

市(区县)：

  

Country：

Vietnam 

Province：

Binh Dinh 

City：

 

单位(医院)：

Binh Dinh Provincial General Hospital 

单位级别：

Provincial 

Institution
hospital：

Binh Dinh Provincial General Hospital

Level of the institution：

Provincial

国家：

 Vietnam

省(直辖市)：

 Binh Dinh 

市(区县)：

  

Country：

Vietnam 

Province：

Binh Dinh 

City：

 

单位(医院)：

Bong Son Regional General Hospital 

单位级别：

Provincial 

Institution
hospital：

Bong Son Regional General Hospital

Level of the institution：

Provincial

国家：

 Vietnam

省(直辖市)：

 Binh Dinh 

市(区县)：

  

Country：

Vietnam 

Province：

Binh Dinh 

City：

 

单位(医院)：

Quy Nhon City Medical Center 

单位级别：

District 

Institution
hospital：

Quy Nhon City Medical Center

Level of the institution：

District

国家：

 Vietnam

省(直辖市)：

 Binh Dinh 

市(区县)：

  

Country：

Vietnam 

Province：

Binh Dinh 

City：

 

单位(医院)：

Phu Cat District Medical Center 

单位级别：

District 

Institution
hospital：

Phu Cat District Medical Center

Level of the institution：

District

国家：

 Vietnam

省(直辖市)：

 Binh Dinh 

市(区县)：

  

Country：

Vietnam 

Province：

Binh Dinh 

City：

 

单位(医院)：

Hoai An District Medical Center 

单位级别：

District 

Institution
hospital：

Hoai An District Medical Center

Level of the institution：

District

测量指标：

Outcomes：

指标中文名：

The effectiveness of the AI-assisted screening strategies, focusing on the detection rates of referable DR and DME.

指标类型：

主要指标

Outcome：

The effectiveness of the AI-assisted screening strategies, focusing on the detection rates of referable DR and DME.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

The incremental cost-effectiveness ratios (ICERs)

指标类型：

次要指标

Outcome：

The incremental cost-effectiveness ratios (ICERs)

Type：

Secondary 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：

正在进行

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）：

A statistician independent of the study team will generate a computer-based random allocation sequence, stratified by age and visual acuity to ensure balanced allocation across the groups.

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

A statistician independent of the study team will generate a computer-based random allocation sequence, stratified by age and visual acuity to ensure balanced allocation across the groups.

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

盲法：

The research assistant will send the participant's stratification information, including age group and VA category, to the study coordinator. The study coordinator will then assign the participant to one of the three groups according to the randomization schedule and notify the research assistant of the group assignment. The study coordinator will manage the flow of information to ensure appropriate allocation of imaging resources. For participants in Intervention Groups 1 and 2, AI-generated reports from both the AI-FP and AI-OCT systems will be provided to the clinicians before making triage decisions. In the Control Group, clinicians will make decisions based solely on their interpretation of the FPs without AI assistance.

Blinding：

The research assistant will send the participant's stratification information, including age group and VA category, to the study coordinator. The study coordinator will then assign the participant to one of the three groups according to the randomization schedule and notify the research assistant of the group assignment. The study coordinator will manage the flow of information to ensure appropriate allocation of imaging resources. For participants in Intervention Groups 1 and 2, AI-generated reports from both the AI-FP and AI-OCT systems will be provided to the clinicians before making triage decisions. In the Control Group, clinicians will make decisions based solely on their interpretation of the FPs without AI assistance.

是否共享原始数据：

IPD sharing

No

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）：

Upload the research to ResMan (www.medrescman.org.cn) half year after publication

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

Upload the research to ResMan (www.medrescman.org.cn) half year after 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：

AI-FP System: Non-mydriatic, macula-centered FPs will be taken for both eyes of each participant, with each image having a 45° field of view using commercial non-mydriatic retinal cameras (Canon CR-2 AF). After image acquisition, the photographs will be transferred and processed by our AI-FP system. AI-OCT System: For participants in the relevant study arms, the research assistant will perform OCT scans using the Cirrus OCT device (Carl Zeiss Meditec, Dublin, CA) with a 6mm × 6mm three-dimensional macular cube scanning protocol (512 A-scans per B-scan; 128 B-scans over 1,024 samplings).

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

AI-FP System: Non-mydriatic, macula-centered FPs will be taken for both eyes of each participant, with each image having a 45° field of view using commercial non-mydriatic retinal cameras (Canon CR-2 AF). After image acquisition, the photographs will be transferred and processed by our AI-FP system. AI-OCT System: For participants in the relevant study arms, the research assistant will perform OCT scans using the Cirrus OCT device (Carl Zeiss Meditec, Dublin, CA) with a 6mm × 6mm three-dimensional macular cube scanning protocol (512 A-scans per B-scan; 128 B-scans over 1,024 samplings).

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：

  2025-01-22 15:27:58