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NCT Number: NCT07747428

Assessment of Retinal Microvascular Changes by OCT Angiography in Diabetic Retinopathy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag Ophthalmology Hospital

Sohag, Egypt

Location status: Recruiting

Location contact

Omnia Mohamed Abdel Aziz, M.B.B.Ch

CONTACT

[email protected]

+201011000347

Omnia Mohamed Abdel Aziz, M.B.B.Ch

PRINCIPAL_INVESTIGATOR

About this study

Diabetic retinopathy is one of the leading causes of visual impairment worldwide. Optical coherence tomography angiography (OCTA) is a non-invasive imaging technique that provides detailed visualization of the retinal microvasculature without the need for dye injection.

This observational cross-sectional study will be conducted at the Department of Ophthalmology, Faculty of Medicine, Sohag University. Adult patients diagnosed with different stages of diabetic retinopathy will undergo comprehensive ophthalmic examination, including best-corrected visual acuity assessment, fundus examination, OCT, and OCT angiography.

Retinal microvascular parameters, including vessel density in the superficial and deep capillary plexuses and the foveal avascular zone (FAZ), will be measured. HbA1c values will be recorded to assess glycemic control.

The primary objective is to evaluate retinal microvascular changes detected by OCTA and determine their correlation with visual acuity and glycemic control across different stages of diabetic retinopathy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Retinal Microvascular Changes Measured by OCT Angiography

    Time frame: Baseline

    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.

Secondary outcomes

  1. Correlation Between OCTA Parameters, Visual Acuity, and Glycemic Control

    Time frame: Baseline

    Evaluation of the association between OCTA-derived retinal microvascular parameters, best-corrected visual acuity, HbA1c level, and the stage of diabetic retinopathy.

Study contacts

Contact information is provided by the study sponsor or research team.

Omnia Mohamed Abdel Aziz, M.B.BCh

CONTACT

[email protected]

01011000347

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Assessment of Retinal Microvascular Changes by OCT Angiography and Their Correlation With Visual Acuity and Glycemic Control Across Different Stages of Diabetic Retinopathy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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