Prevalence of Diabetic Retinopathy in Type 2 Diabetic Patients

Not yet recruiting

• Conditions: Diabetic Retinopathy

• Registration Number: NCT06146699
• Lead Sponsor: Assiut University

Brief Summary

To determine the stage of Diabetic Retinopathy (DR) and the presenting symptoms at the time of ophthalmological examination of diabetic individuals .

Detailed Description

Diabetic retinopathy (DR) is the main cause of decreased vision and blindness in patients with diabetes throughout the world . In Egypt, the estimated prevalence of diabetes mellitus (DM) is expected to rise from 5-10% in the 1990s to\>13% of the population over 20 years old by 2025 .

The estimation of the prevalence of diabetic retinopathy (DR) is challenging due to the great variation in the study populations, methodologies, and grading schemes .

Globally, the prevalence of DR and diabetic macular edema (DMO) is expected to rise from the estimates for the period 2015-2019 (27%) due to the expected increase in the life expectancy of people living with DM .

Diabetic retinopathy is now the 5th leading cause of blindness worldwide and is the main cause of blindness in working population .

Blindness due to diabetic retinopathy is more common in type 1 diabetics (4%) than in type 2 (1.6%) .

The exact mechanism of how prolonged hyperglycaemia causes retinopathy is still unclear, however studies have shown that prolonged hyperglycaemia alters retinal perfusion thereby disturbing the normal physiological and homeostatic state of the retina, in turn causing retinopathy .

Fortunately, much of the visual loss from DR is preventable, and the rates of vision loss from diabetes and DR have steadily declined over the past few decades. Such improvements in visual outcomes for DR are multifactorial, and are due in large part to a combination of better systemic risk factor control, coupled with advances in ocular disease assessment, screening, imaging and treatment in recent years .

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-18
• Study First Submitted QC: 2023-11-18
• Last Update Submitted: 2023-11-24
• Study First Posted: 2023-11-27
• Last Update Posted: 2023-11-29
• Study Start: 2023-12
• Primary Completion: 2024-12
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 262

Inclusion Criteria

• All known diabetic patients ( type 2 ) or patients who were later on diagnosed with type 2 diabetes mellitus as per American Diabetes Association (ADA) criteria who presented for the first time to Assuit university hospital opthalomolgy outpatient clinics during study duration (one year) will be included in the study . Diabetic retinopathy will be classified according to Early Treatment Diabetic Retinopathy Study (ETDRS) classification as mild, moderate, severe and very severe non proliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR). Patients with vitreous hemorrhage, rubeosis iridis, neovascular glaucoma or tractional retinal detachment will be classified as having advanced diabetic eye disease (ADED).

Exclusion Criteria

• Type 1 Diabetic patients or patients with diabetes below 25 years old will be excluded from the study .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of diabetic retinopathy	Baseline	To determine the stage of Diabetic Retinopathy (DR) and the presenting symptoms at the time of ophthalmological examination of diabetic individuals .