Color Fundus Photograph With Experts Labelling

Recruiting

• Conditions: Diabetic Retinopathy; Retinal Disease

• Registration Number: NCT06287645
• Lead Sponsor: Pakistan Council of Scientific and Industrial Research

Brief Summary

This trial aims to provide a digital retinal image dataset from Pakistan, graded by three specialists according to the severity of Diabetic Retinopathy. The dataset aims to improve research and patient care.

Detailed Description

This clinical trial aims to address the scarcity of retinal image datasets in Pakistan by providing a comprehensive digital fundus photograph dataset, accompanied by expert grading. The dataset will encompass retinal images from Pakistani individuals, meticulously labeled by three Vitreo Retinal Specialists. These specialists will assess the presence and severity of common retinal disorders, including No Diabetic Retinopathy (No DR), Mild, Moderate, Severe, Proliferative Diabetic Retinopathy, Clinically Significant Macular Edema (CSME), and Advance diabetic Eye Diseases (ADED). Each image will also be evaluated for diagnostic clarity and the presence of any additional findings. Final grading decisions will be reached through unanimous consensus among the graders, ensuring the dataset's reliability and accuracy. This initiative holds promise for advancing ophthalmic research and improving patient care in Pakistan and beyond.

Study Timeline

• Study Start: 2022-05-12
• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-29
• Status Verified: 2024-03
• Study First Posted: 2024-03-01
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

• Patients with Type I or Type II Diabetes.
• Patients of age of 20 years or above

Exclusion Criteria

• The participant is unable or unwilling to comply with study procedures.
• Vulnerable participants (minors, legally detained individuals).
• Prisoners or subjects who are involuntarily incarcerated.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale	1 Visit (1 day)	Each Fundus photograph will be evaluated according to the Severity of Diabetic Retinopathy following Early Treatment of Diabetic Retinopathy Scale (ETDRS). Following Diabetic Retinopathy symptoms will be graded according to this scale.; 1. Clinically Significant Macular Edema; 2. Advance Diabetic Eye Disease
Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale	1 Visit (1 day)	Each Fundus photograph will be evaluated according to the Severity of Diabetic Retinopathy following International Clinical Diabetic Retinopathy Severity Scale (ICDRSS). Following Diabetic Retinopathy symptoms will be graded according to this scale.; 1. No DR; 2. Mild; 3. Moderate; 4. Severe; 5. Proliferative
Finding inter-rater agreement among the graders	Two Years	The intraclass correlation coefficient will be calculated using the collected dataset to assess the consistency in grading among all graders.

Trial Locations

Locations (1)

Al Ibrahim Eye Hospital; 🇵🇰 Karachi, Pakistan