Color Fundus Photograph With Experts Labelling

NCT06287645 | Recruiting

• 1 other identifier: Retinal Images Dataset
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Disease; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (3)

• 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. 1. No DR 2. Mild 3. Moderate 4. Severe 5. Proliferative

  1 Visit (1 day)

• 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. 1. Clinically Significant Macular Edema 2. Advance Diabetic Eye Disease

  1 Visit (1 day)

• 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

Interventions

Color Fundus Photography/Non-Mydriatic Opthalmic Cameras DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting the diabetic eye care center at our collaborated hospital will be registered for this study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pakistan Council of Scientific and Industrial Research: lead
• Al-Ibrahim Eye Hospital: collaborator

Study Sites (1)

Al Ibrahim Eye Hospital

Karachi, Pakistan

RECRUITING

MeSH Terms

Conditions

Retinal Diseases; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Ghulam Mustafa

  Pakistan Council of Scientific and Industrial Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghulam Mustafa

CONTACT

+923322340395; mustafabme@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 1, 2024
• Study Start: May 12, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

PA (1)