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Diabetic Retinopathy (DR)RetinopathyNCT07726381

Relation Between Glycemic Control and Retinal Microvascular Changes in Diabetic Patients Using OCTA

An observational study of Diabetic Retinopathy (DR) and Retinal Microvascular Changes, run by Sohag University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

An observational cross-sectional comparative study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt to detect the relation between glycemic control and retinal microvascular changes in diabetic patients using OCTA Read more about this study

Who is it for?
Any age
How many people
50 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 1 Feb 2027
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 50 eyes of diabetic patients with with diabetic retinopathy with controlled and uncontrolled HbA1c

Who may be able to join

  • Diabetic patients with diabetic retinopathy with controlled and uncontrolled HbA1c

Who cannot join

  • Media opacities affecting OCT imaging (corneal pathologies, dense cataracts, vitreous opacities, etc).
  • Patients with any other retinal vascular diseases (retinal vein occlusion, central serrous chorioretinopathy, age-related macular degeneration, etc).
  • Patients who have had previous intravitreal injections or Laser treatment.
  • Patients who underwent previous vitreoretinal surgeries.
  • Patients with recent history of undergoing cataract surgery.
  • Patients with uncontrolled glaucoma or ocular inflammations (eg: vitritis).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Nourhan Ahmed, Resident contact

+201144486792

nourhanaymanpost@med.sohag.edu.eg

Sara Mahmoud, Lecturer contact

About this study

An observational cross-sectional comparative study which will be conducted in the Department of Ophthalmology, Sohag University Hospital, Egypt to detect the relation between glycemic control and retinal microvascular changes in diabetic patients using OCTA

Read the detailed description

Diabetes is one of the fastest growing diseases worldwide, projected to affect 693 million adults by 2045. Devastating macrovascular complications (cardiovascular disease) and microvascular complications (such as diabetic kidney disease, diabetic retinopathy and neuropathy) lead to increased mortality, blindness, kidney failure and an overall decreased quality of life in individuals with diabetes Diabetic retinopathy (DR) is the major ocular complication of diabetes mellitus, and occurs in about 30 to 40% of diabetic individuals. Globally, more than 100 million individuals are living with DR, and DR is a leading cause of blindness and visual impairment, especially among the working-age adult population. Fortunately, much of the visual loss from DR is preventable, and the rates of vision loss from diabetes and DR have steadily declined over the past few decades. Such improvements in visual outcomes for DR are multifactorial, and are mainly due to a combination of better systemic risk factor control, coupled with advances in ocular disease assessment, screening, imaging and treatment in recent years.

From a haemodynamic perspective, evidence suggests that there is an early reduction in retinal perfusion before the onset of diabetic retinopathy followed by a gradual increase in blood flow as the complication progresses. Early changes in the retinal microcirculation include disruptions in blood flow, thickening of basement membrane, eventual loss of mural cells, and the genesis of acellular capillaries. Endothelial apoptosis and capillary dropout lead to a hypoxic inner retina, alterations in growth factors, and upregulation of inflammatory mediators.

The retinal blood vessels provide the opportunity to study early structural and functional changes in the microvasculature prior to clinically significant microvascular and macrovascular complications of diabetes. Advances in digital retinal photography and computerised assessment of the retinal vasculature have provided more objective and precise measurements of retinal vascular changes.

Optical coherence tomography (OCT) is a non-contact imaging technique which generates cross-sectional images of tissue with high resolution. Therefore it is especially valuable in organs, where traditional microscopic tissue diagnosis by means of biopsy is not available-such as the human eye.

Optical coherence tomography angiography (OCTA) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information generating angiographic images in a matter of seconds.

HbA1c is used as an index to reflect the average blood glucose levels of the past 1-2 months. A study in which HbA1c and the incidence of diabetic retinopathy were observed in a cross-sectional manner reported that the risk of onset of diabetes was high when HbA1c was 6.0% or more and less than 6.5%. Several studies have compared the sensitivity and specificity of fasting plasma glucose (FPG) and HbA1c in diabetic retinopathy detection. Many cross-sectional studies have reported that HbA1c was able to detect diabetic retinopathy more accurately.

This study will include 50 eyes of diabetic patients divided into: Group 1: 25 eyes of diabetic patients with controlled HbA1c Group 2: 25 eyes of diabetic patients with uncontrolled HbA1c, in the Department of Ophthalmology, Sohag University Hospital.

Keywords
retinal microvascular changes, diabetic retinopathy, Optical coherence topography
Medical subject headings
Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07726381
Study groupRoleWhat they receive
This study will include 50 eyes of diabetic patients divided into: Group 1: 25 eyes of diabetic patiThis study will include 50 eyes of diabetic patients divided into: Group 1: 25 eyes of diabetic patients with controlled HbA1c Group 2: 25 eyes of diabetic patients with uncontrolled HbA1c,

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OCT findings

    OCTA images and data will be collected and analysed from the electronic medical reports for all patients to detect micro-vascular changes in the form of :

    1. Vascular density ( superficial and deep plexuses )in square millimeters (mm²).
    2. Foveal Avascular Zone ( FAZ ) in percentage

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07726381
Sponsor's protocol ID
Sohag university
Acronym
Retinopathy
Status last verified
Jul 2026
First submitted
20 Jul 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Retinopathy (DR) and Retinal Microvascular Changes, run by Sohag University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nourhan Ahmed, Resident (+201144486792, nourhanaymanpost@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OCT findings (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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