Prevalence of Diabetic Retinopathy in Type 2 Diabetic Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06146699
Collaborator
(none)
262
14.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Optical Coherence Tomography (OCT)
  • Device: Fundus fluorescein angiography (FFA)

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 Design

Study Type:
Observational
Anticipated Enrollment :
262 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Status of Diabetic Retinopathy and Its Presentation Patterns in Diabetics at Assiut University Hospital
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 90 Years
Sexes Eligible for Study:
All
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 .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Ashraf K. Al-Hussaini, prof, Assiut University
  • Study Director: Ahmed M. Fahmy Fathalla, prof, Assiut University
  • Study Director: Islam M. Mohamed Gouda, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abdelrahman Mohamed Abdelhafez Mohamed, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT06146699
Other Study ID Numbers:
  • Diabetic Retinopathy
First Posted:
Nov 27, 2023
Last Update Posted:
Nov 29, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2023