Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography

the aim of this study is to assess the impact of duration of DM on OCTA parameters in diabetic patients without clinical Diabetic retinopathy.

Study Overview

• Status: Completed
• Conditions: Diabetic Retinopathy, DR
• Intervention / Treatment: Diagnostic test: optical coherence tomography angiography

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Egypt
  • Sohag Governorate
    • Sohag, Sohag Governorate, Egypt, 82749
      • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

patients will be recruited from diabetics who will present for retinopathy screening examination at outpatient clinic of Sohag University Hospital.

Description

Inclusion Criteria:

1. Type of DM: Type 2.
2. Fundus examination: no macular edema or other signs of clinical retinopathy

Exclusion Criteria:

1. Ocular history : any history of significant ocular injury or disease that could affect the retinal microvasculature such as retinal vascular occlusion, glaucoma, or vitreo-macular disease, as such conditions have also been noted to show sub-clinical OCTA changes [13, 14].
2. Fundus examination: macular edema or any other signs of clinical retinopathy

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-diabetic; patients who are above 40 years old and don't have diabetes	Diagnostic test: optical coherence tomography angiography; A non-invasive eye imaging technique that creates high-resolution, 3D maps of blood flow in the retina and choroid by comparing sequential OCT scans to detect the motion of red blood cells to provide a visual contrast to the static tissue that allows the visualization the retinal microvasculature without needing an injectable dye, unlike traditional angiography.
diabetic (0-5y); patients who are above 40 years old and have diabetes for less than 5 years	Diagnostic test: optical coherence tomography angiography; A non-invasive eye imaging technique that creates high-resolution, 3D maps of blood flow in the retina and choroid by comparing sequential OCT scans to detect the motion of red blood cells to provide a visual contrast to the static tissue that allows the visualization the retinal microvasculature without needing an injectable dye, unlike traditional angiography.
diabetics (5-10y); patients who are above 40 years old and have diabetes for 5-10 years	Diagnostic test: optical coherence tomography angiography; A non-invasive eye imaging technique that creates high-resolution, 3D maps of blood flow in the retina and choroid by comparing sequential OCT scans to detect the motion of red blood cells to provide a visual contrast to the static tissue that allows the visualization the retinal microvasculature without needing an injectable dye, unlike traditional angiography.
diabetics (10y < ); patients who are above 40 years old and have diabetes for more than 10 years	Diagnostic test: optical coherence tomography angiography; A non-invasive eye imaging technique that creates high-resolution, 3D maps of blood flow in the retina and choroid by comparing sequential OCT scans to detect the motion of red blood cells to provide a visual contrast to the static tissue that allows the visualization the retinal microvasculature without needing an injectable dye, unlike traditional angiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FAZ metrics	FAZ area, FAZ perimeter & FAZ flow density	baseline
Superficial Vessel Density	foveal, average parafoveal & average perifoveal	baseline
Deep Vessel Density	foveal, average parafoveal, average perifoveal	baseline
SCP thickness	foveal, average parafoveal & average perifoveal	baseline
DCP thickness	foveal, average parafoveal & average perifoveal	baseline
Sectoral superficial vessel density	superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal & temporal perifoveal	baseline
Sectoral deep vessel density	superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal & temporal perifoveal	baseline

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Rao HL, Pradhan ZS, Suh MH, Moghimi S, Mansouri K, Weinreb RN. Optical Coherence Tomography Angiography in Glaucoma. J Glaucoma. 2020 Apr;29(4):312-321. doi: 10.1097/IJG.0000000000001463.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 8, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: Soh-Med-24-05-16MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No