Color Fundus Photograph With Experts Labelling

NCT ID: NCT06287645

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-12

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Retinal Disease Diabetic Retinopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Ibrahim Eye Hospital

OTHER

Sponsor Role collaborator

Pakistan Council of Scientific and Industrial Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ghulam Mustafa

Role: PRINCIPAL_INVESTIGATOR

Pakistan Council of Scientific and Industrial Research

Locations

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Al Ibrahim Eye Hospital

Karachi, , Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Ghulam Mustafa

Role: CONTACT

+923322340395

Facility Contacts

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Ghulam Mustafa

Role: primary

Other Identifiers

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Retinal Images Dataset

Identifier Type: -

Identifier Source: org_study_id

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