Color Fundus Photograph With Experts Labelling

Diabetic Retinopathy Clinical Trial

Official title:

Development of Digital Fundus Images Dataset of Local Population of Pakistan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287645
• Other study ID #: Retinal Images Dataset
• Status: Recruiting
• Start date: May 12, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Pakistan Council of Scientific and Industrial Research
• Contact: Ghulam Mustafa
• Phone: +923322340395
• Email: mustafabme[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Disease
• Retinal Diseases

Intervention

Diagnostic Test:
• Color Fundus Photography/Non-Mydriatic Opthalmic Cameras
Participants will undergo retinal imaging by fundus camera. Three specialists will independently grade images for common retinal disorders like Diabetic Retinopathy. Final grading decisions will be unanimous among the specialists.

Locations

Country	Name	City	State
Pakistan	Al Ibrahim Eye Hospital	Karachi

Sponsors (2)

Lead Sponsor	Collaborator
Pakistan Council of Scientific and Industrial Research	Al-Ibrahim Eye Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale	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.; No DR; Mild; Moderate; Severe; Proliferative	1 Visit (1 day)
Primary	Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale	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.; Clinically Significant Macular Edema; Advance Diabetic Eye Disease	1 Visit (1 day)
Primary	Finding inter-rater agreement among the graders	The intraclass correlation coefficient will be calculated using the collected dataset to assess the consistency in grading among all graders.	Two Years