Diabetic RetinopathyNCT07747428
Assessment of Retinal Microvascular Changes by OCT Angiography in Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Sohag University at 1 site in Egypt.
Trial summary
This observational cross-sectional study aims to assess retinal microvascular changes using optical coherence tomography angiography (OCTA) in patients with diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 31 Dec 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18-80 years) with diabetic retinopathy attending the Ophthalmology Department, Sohag University Hospital, who meet the eligibility criteria and undergo OCT angiography and complete ophthalmic examination.
Who may be able to join
- -
- Adults aged 18 to 80 years.
- Patients diagnosed with diabetic retinopathy.
- Ability to undergo complete ophthalmic examination including OCT and OCT angiography.
- Availability of HbA1c measurement within the study period.
- Ability and willingness to provide written informed consent.
Who cannot join
- Previous vitreoretinal surgery.
- Significant media opacity affecting image quality (e.g., dense cataract or vitreous hemorrhage).
- Other retinal vascular diseases (e.g., retinal vein occlusion).
- Glaucoma or optic nerve diseases affecting visual function.
- High myopia (>6 diopters).
- Poor-quality OCTA images due to motion artifacts or poor fixation.
- Refusal or inability to provide informed consent.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sohag Ophthalmology Hospital
Sohag
Omnia Mohamed Abdel Aziz, M.B.B.Ch, +201011000347, 01011000347a@gmail.com
Omnia Mohamed Abdel Aziz, M.B.B.Ch
About this study
Official title: Assessment of Retinal Microvascular Changes by OCT Angiography and Their Correlation With Visual Acuity and Glycemic Control Across Different Stages of Diabetic Retinopathy
This observational cross-sectional study aims to assess retinal microvascular changes using optical coherence tomography angiography (OCTA) in patients with diabetic retinopathy. The study will evaluate retinal vessel density and foveal avascular zone parameters and investigate their correlation with best-corrected visual acuity and glycemic control (HbA1c) across different stages of diabetic retinopathy. The findings may improve understanding of retinal microvascular alterations and their clinical significance.
Read the detailed description
Diabetic retinopathy is one of the leading causes of visual impairment worldwide. Optical coherence tomography angiography (OCTA) is a non-invasive imaging technique that provides detailed visualization of the retinal microvasculature without the need for dye injection.
This observational cross-sectional study will be conducted at the Department of Ophthalmology, Faculty of Medicine, Sohag University. Adult patients diagnosed with different stages of diabetic retinopathy will undergo comprehensive ophthalmic examination, including best-corrected visual acuity assessment, fundus examination, OCT, and OCT angiography.
Retinal microvascular parameters, including vessel density in the superficial and deep capillary plexuses and the foveal avascular zone (FAZ), will be measured. HbA1c values will be recorded to assess glycemic control.
The primary objective is to evaluate retinal microvascular changes detected by OCTA and determine their correlation with visual acuity and glycemic control across different stages of diabetic retinopathy.
- Conditions
- Diabetic Retinopathy
- Keywords
- Optical Coherence Tomography Angiography, OCTA, Retinal Microvasculature, Diabetic Retinopathy, Visual Acuity, HbA1c, Vessel Density
- Medical subject headings
- Diabetic Retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal Microvascular Changes Measured by OCT Angiography
Assessment of retinal microvascular parameters including vessel density in the superficial and deep capillary plexuses and the foveal avascular zone (FAZ) using OCT angiography, and their correlation with best-corrected visual acuity and HbA1c.
Measured: Baseline
Secondary outcomes (1)
Correlation Between OCTA Parameters, Visual Acuity, and Glycemic Control
Evaluation of the association between OCTA-derived retinal microvascular parameters, best-corrected visual acuity, HbA1c level, and the stage of diabetic retinopathy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Mohamed Abdelziz, Sohag University
- Investigators
- Ahmad Gad Kamel, Study chair, Faculty of Medicine, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747428
- Sponsor's protocol ID
- Soh-Med-26-6-21MS
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Retinal Microvascular Changes by OCT Angiography and Their Correlation With Visual Acuity and Glycemic Control Across Different Stages of Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT07747428
- Acronym / sponsor ID
- Soh-Med-26-6-21MS
- Conditions
- Diabetic Retinopathy
- Keywords
- Optical Coherence Tomography Angiography, OCTA, Retinal Microvasculature, Diabetic Retinopathy, Visual Acuity, HbA1c, Vessel Density
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational cross-sectional study aims to assess retinal microvascular changes using optical coherence tomography angiography (OCTA) in patients with diabetic retinopathy. The study will evaluate retinal vessel density and foveal avascular zone parameters and investigate their correlation with best-corrected visual acuity and glycemic control (HbA1c) across different stages of diabetic retinopathy. The findings may improve understanding of retinal microvascular alterations and their clinical significance.
Detailed description
Diabetic retinopathy is one of the leading causes of visual impairment worldwide. Optical coherence tomography angiography (OCTA) is a non-invasive imaging technique that provides detailed visualization of the retinal microvasculature without the need for dye injection.
This observational cross-sectional study will be conducted at the Department of Ophthalmology, Faculty of Medicine, Sohag University. Adult patients diagnosed with different stages of diabetic retinopathy will undergo comprehensive ophthalmic examination, including best-corrected visual acuity assessment, fundus examination, OCT, and OCT angiography.
Retinal microvascular parameters, including vessel density in the superficial and deep capillary plexuses and the foveal avascular zone (FAZ), will be measured. HbA1c values will be recorded to assess glycemic control.
The primary objective is to evaluate retinal microvascular changes detected by OCTA and determine their correlation with visual acuity and glycemic control across different stages of diabetic retinopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-80 years) with diabetic retinopathy attending the Ophthalmology Department, Sohag University Hospital, who meet the eligibility criteria and undergo OCT angiography and complete ophthalmic examination.
Key inclusion criteria (6 listed)
- -
- Adults aged 18 to 80 years.
- Patients diagnosed with diabetic retinopathy.
- Ability to undergo complete ophthalmic examination including OCT and OCT angiography.
- Availability of HbA1c measurement within the study period.
Key exclusion criteria (8 listed)
- Previous vitreoretinal surgery.
- Significant media opacity affecting image quality (e.g., dense cataract or vitreous hemorrhage).
- Other retinal vascular diseases (e.g., retinal vein occlusion).
- Glaucoma or optic nerve diseases affecting visual function.
- High myopia (>6 diopters).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retinal Microvascular Changes Measured by OCT Angiography
Time frame: Baseline
Assessment of retinal microvascular parameters including vessel density in the superficial and deep capillary plexuses and the foveal avascular zone (FAZ) using OCT angiography, and their correlation with best-corrected visual acuity and HbA1c.
1 secondary outcome
Correlation Between OCTA Parameters, Visual Acuity, and Glycemic Control
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmad Gad Kamel study chair
Faculty of Medicine, Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Sohag University at 1 site in Egypt.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Omnia Mohamed Abdel Aziz, M.B.BCh (01011000347, 01011000347a@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal Microvascular Changes Measured by OCT Angiography (time frame: Baseline). 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 5 Aug 2026.