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

December 14, 2025 updated by: Mohamed Abdou Saeed, Sohag University
the aim of this study is to assess the impact of duration of DM on OCTA parameters in diabetic patients without clinical Diabetic retinopathy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypt, 82749
        • Sohag university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
non-diabetic
patients who are above 40 years old and don't have diabetes
Diagnostic test: optical 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.
diabetic (0-5y)
patients who are above 40 years old and have diabetes for less than 5 years
Diagnostic test: optical 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.
diabetics (5-10y)
patients who are above 40 years old and have diabetes for 5-10 years
Diagnostic test: optical 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.
diabetics (10y < )
patients who are above 40 years old and have diabetes for more than 10 years
Diagnostic test: optical 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FAZ metrics
Time Frame: baseline
FAZ area, FAZ perimeter & FAZ flow density
baseline
Superficial Vessel Density
Time Frame: baseline
foveal, average parafoveal & average perifoveal
baseline
Deep Vessel Density
Time Frame: baseline
foveal, average parafoveal, average perifoveal
baseline
SCP thickness
Time Frame: baseline
foveal, average parafoveal & average perifoveal
baseline
DCP thickness
Time Frame: baseline
foveal, average parafoveal & average perifoveal
baseline
Sectoral superficial vessel density
Time Frame: baseline
superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal & temporal perifoveal
baseline
Sectoral deep vessel density
Time Frame: baseline
superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal & temporal perifoveal
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Soh-Med-24-05-16MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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