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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06457295
Enrollment
200
Registered
2024-06-13
Start date
2024-12-20
Completion date
2025-09-01
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy, DR

Brief summary

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

Interventions

DIAGNOSTIC_TESToptical 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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
FAZ metricsbaselineFAZ area, FAZ perimeter & FAZ flow density
Superficial Vessel Densitybaselinefoveal, average parafoveal & average perifoveal
Deep Vessel Densitybaselinefoveal, average parafoveal, average perifoveal
SCP thicknessbaselinefoveal, average parafoveal & average perifoveal
DCP thicknessbaselinefoveal, average parafoveal & average perifoveal
Sectoral superficial vessel densitybaselinesuperior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal & temporal perifoveal
Sectoral deep vessel densitybaselinesuperior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal & temporal perifoveal

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026