Assessment of Retinal Microvascular Changes by OCT Angiography in Diabetic Retinopathy

NCT07747428 | Recruiting

• 1 other identifier: Soh-Med-26-6-21MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This observational cross-sectional study aims to assess retinal microvascular changes using optical coherence tomography angiography (OCTA) in patients with diabetic retinopathy. The study will evaluate retinal vessel density and foveal avascular zone parameters and investigate their correlation with best-corrected visual acuity and glycemic control (HbA1c) across different stages of diabetic retinopathy. The findings may improve understanding of retinal microvascular alterations and their clinical significance.

Conditions

Diabetic Retinopathy

Keywords

Optical Coherence Tomography Angiography; OCTA; Retinal Microvasculature; Diabetic Retinopathy; Visual Acuity; HbA1c; Vessel Density

Outcome Measures

Primary Outcomes (1)

• Retinal Microvascular Changes Measured by OCT Angiography

  Assessment of retinal microvascular parameters including vessel density in the superficial and deep capillary plexuses and the foveal avascular zone (FAZ) using OCT angiography, and their correlation with best-corrected visual acuity and HbA1c.

  Baseline

Secondary Outcomes (1)

• Correlation Between OCTA Parameters, Visual Acuity, and Glycemic Control

  Baseline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18-80 years) with diabetic retinopathy attending the Ophthalmology Department, Sohag University Hospital, who meet the eligibility criteria and undergo OCT angiography and complete ophthalmic examination.

You may qualify if:

• Adults aged 18 to 80 years.
• Patients diagnosed with diabetic retinopathy.
• Ability to undergo complete ophthalmic examination including OCT and OCT angiography.
• Availability of HbA1c measurement within the study period.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Previous vitreoretinal surgery.
• Significant media opacity affecting image quality (e.g., dense cataract or vitreous hemorrhage).
• Other retinal vascular diseases (e.g., retinal vein occlusion).
• Glaucoma or optic nerve diseases affecting visual function.
• High myopia (\>6 diopters).
• Poor-quality OCTA images due to motion artifacts or poor fixation.
• Refusal or inability to provide informed consent.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag Ophthalmology Hospital

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Ahmad Gad Kamel

  Faculty of Medicine, Sohag University

  STUDY CHAIR

Central Study Contacts

Omnia Mohamed Abdel Aziz, M.B.BCh

CONTACT

01011000347; 01011000347a@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Altahrir street sohag

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)