Color Fundus Photograph With Experts Labelling

March 5, 2024 updated by: Pakistan Council of Scientific and Industrial Research

Development of Digital Fundus Images Dataset of Local Population of Pakistan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finding inter-rater agreement among the graders
Time Frame: Two Years
The intraclass correlation coefficient will be calculated using the collected dataset to assess the consistency in grading among all graders.
Two Years
Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale
Time Frame: 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
1 Visit (1 day)
Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale
Time Frame: 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
1 Visit (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Council of Scientific and Industrial Research

Collaborators

Al-Ibrahim Eye Hospital

Investigators

  • Principal Investigator: Ghulam Mustafa, Pakistan Council of Scientific and Industrial Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Retinal Images Dataset

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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