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OpenTrials
Completed

NCT Number: NCT06457295

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.

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Key information

Conditions

Diabetic Retinopathy, DR Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag university hospital

Sohag, Sohag Governorate, 82749, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

Exclusion criteria

  • 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].
  • Fundus examination: macular edema or any other signs of clinical retinopathy

Treatment and study plan

Optical Coherence tomography angiography

Diagnostic Test

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.

Primary outcomes

  1. FAZ metrics

    Time frame: baseline

    FAZ area, FAZ perimeter & FAZ flow density

  2. Superficial Vessel Density

    Time frame: baseline

    foveal, average parafoveal & average perifoveal

  3. Deep Vessel Density

    Time frame: baseline

    foveal, average parafoveal, average perifoveal

  4. SCP thickness

    Time frame: baseline

    foveal, average parafoveal & average perifoveal

  5. DCP thickness

    Time frame: baseline

    foveal, average parafoveal & average perifoveal

  6. Sectoral superficial vessel density

    Time frame: baseline

    superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal & temporal perifoveal

  7. Sectoral deep vessel density

    Time frame: baseline

    superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal & temporal perifoveal

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2024
Registry last updated
Dec 19, 2025

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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