Diabetic Retinopathy, Retinal Disease
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTColor 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.
Sponsors
Al-Ibrahim Eye Hospital
Pakistan Council of Scientific and Industrial Research
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grading Diabetic Retinopathy Severity according to International Clinical Diabetic Retinopathy Severity Scale | 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 |
| Grading Diabetic Retinopathy Severity according to Early Treatment of Diabetic Retinopathy Scale | 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 |
| Finding inter-rater agreement among the graders | Two Years | The intraclass correlation coefficient will be calculated using the collected dataset to assess the consistency in grading among all graders. |
Countries
Pakistan
Contacts
Primary ContactGhulam Mustafa
Outcome results
None listed