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

NCT06457295 | Completed DMC

• 1 other identifier: Soh-Med-24-05-16MS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy, DR

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (4)

non-diabetic

patients who are above 40 years old and don't have diabetes

Diagnostic Test: optical coherence tomography 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

diabetics (5-10y)

patients who are above 40 years old and have diabetes for 5-10 years

Diagnostic Test: optical coherence tomography angiography

diabetics (10y < )

patients who are above 40 years old and have diabetes for more than 10 years

Diagnostic Test: optical coherence tomography angiography

Interventions

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.

diabetic (0-5y); diabetics (10y < ); diabetics (5-10y); non-diabetic

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university hospital

Sohag, Sohag Governorate, 82749, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32053551 RESULT

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 Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 13, 2024
• Study Start: December 20, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 19, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)