About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with Type I or Type II Diabetes.
Patients of age of 20 years or above
Disqualifiers
The participant is unable or unwilling to comply with study procedures.
Vulnerable participants (minors, legally detained individuals).
Prisoners or subjects who are involuntarily incarcerated.
Trial population
Patients visiting the diabetic eye care center at our collaborated hospital will be registered for this study.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Color Fundus Photography/Non-Mydriatic Opthalmic Cameras
Diagnostic testParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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
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.
Sponsors and contacts
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Pakistan Council of Scientific and Industrial Research
Lead sponsor
Al-Ibrahim Eye Hospital
Collaborator