## Protocol Section
### Identification Module
**NCT ID:** NCT06423274

**Brief Title:** Comparing Artificial Intelligence for Assisted Diagnosis of Diabetic Retinopathy

**Official Title:** A Comparative Analysis of the Diagnostic Outcomes of Artificial Intelligence-assisted Fundus Photography for Diabetic Retinopathy and Diabetic Macular Edema Versus Other Imaging Devices in Ophthalmology: A Controlled Trial

#### Organization Study ID Info
**ID:** DR artificial intelligence
#### Organization
**Class:** OTHER
**Full Name:** Zhejiang University
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Zhejiang University

#### Responsible Party

**Investigator Affiliation:** Second Affiliated Hospital, School of Medicine, Zhejiang University

**Investigator Full Name:** Wu Hongkang

**Investigator Title:** Director

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.

**Detailed Description:** This study plans to compare the accuracy of artificial intelligence (AI)-assisted fundus images with other ophthalmic devices such as optical coherence tomography (OCT) and fundus fluorescence angiography (FFA) in the diagnosis of diabetic retinopathy and diabetic macular edema.

This study was conducted as a prospective study. Participants meeting eligibility criteria will be recruited from sites staffed by trained photographers. After assessing eligibility and obtaining informed consent, fundus photographs will be taken using a non-dilated fundus camera. And optical coherence tomography or fundus fluorescence angiography will be performed.

### Conditions Module

**Conditions:**

- Diabetic Retinopathy

- Diabetic Macular Edema

**Keywords:**

- diabetic retinopathy

- diabetic macular edema

- artificial intelligence

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Artificial intelligence-assisted fundus photography in patients with diabetic retinopathy

**Intervention Names:**

- Diagnostic Test: fundus photography

**Label:** artificial intelligence-assisted fundus photography

#### Arm Group 2

**Description:** optical coherence tomography in patients with diabetic retinopathy

**Intervention Names:**

- Diagnostic Test: optical coherence tomography

**Label:** optical coherence tomography

#### Arm Group 3

**Description:** fundus fluorescence angiography in patients with diabetic retinopathy

**Intervention Names:**

- Diagnostic Test: fundus fluorescence angiography

**Label:** fundus fluorescence angiography

### Interventions

#### Intervention 1

**Arm Group Labels:**

- artificial intelligence-assisted fundus photography

**Description:** using artificial intelligence to identify diabetic retinopathy using fundus photography

**Name:** fundus photography

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- optical coherence tomography

**Description:** detect diabetic retinopathy and diabetic macular edema by optical coherence tomography

**Name:** optical coherence tomography

**Type:** DIAGNOSTIC_TEST

#### Intervention 3

**Arm Group Labels:**

- fundus fluorescence angiography

**Description:** detect diabetic retinopathy by fundus fluorescence angiography

**Name:** fundus fluorescence angiography

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Detection of DR accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography

**Measure:** The accuracy

**Time Frame:** Baseline-Month 12

#### Secondary Outcomes

**Description:** Detection of DME accuracy using fundus photography, optical coherence tomography, and fundus fluorescence angiography

**Measure:** The accuracy

**Time Frame:** Baseline-Month 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Diagnostic for diabetes: Type 1 diabetes of a lest 5 years of evolution; or Type 2 diabetes;
2. Obtaining informed consent;
3. Patient age 18 or above.

Exclusion Criteria:

1. Patients under 18 years of age;
2. Failure to Obtain informed consent;
3. Presence of other retinal diseases;
4. A patient who has already undergone the treatment.

**Healthy Volunteers:** True

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** It is planned to include 1,000 participants in the study, all of whom will undergo fundus photography, 500 additional patients will undergo fundus fluorescence angiography, and 500 additional patients will undergo optical coherence tomography.

All participants met inclusion and exclusion criteria.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wuhongkang@zju.edu.cn

**Name:** Hongkang Wu, MMS

**Phone:** +8618969978676

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hangzhou

**Contacts:**

***Contact 1:***

- **Email:** wuhongkang@zju.edu.cn

- **Name:** Hongkang Wu, MMS

- **Phone:** 18969978676

- **Role:** CONTACT

**Country:** China

**Facility:** The Second Affiliated Hospital Zhejiang University School of Medicine

**State:** Zhejiang

**Zip:** 310000

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000008268

- Term: Macular Degeneration

- ID: D000012162

- Term: Retinal Degeneration

- ID: D000005128

- Term: Eye Diseases

- ID: D000003925

- Term: Diabetic Angiopathies

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000048909

- Term: Diabetes Complications

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M11261

- Name: Macular Edema

- Relevance: HIGH

- As Found: Macular Edema

- ID: M7125

- Name: Diabetic Retinopathy

- Relevance: HIGH

- As Found: Diabetic Retinopathy

- ID: M14999

- Name: Retinal Diseases

- Relevance: HIGH

- As Found: Retinopathy

- ID: M7657

- Name: Edema

- Relevance: HIGH

- As Found: Edema

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11260

- Name: Macular Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M14997

- Name: Retinal Degeneration

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7120

- Name: Diabetic Angiopathies

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26004

- Name: Diabetes Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008269

- Term: Macular Edema

- ID: D000012164

- Term: Retinal Diseases

- ID: D000003930

- Term: Diabetic Retinopathy

- ID: D000004487

- Term: Edema

### Misc Info Module

- Version Holder: 2024-05-31
