Diabetic Retinopathy, DRNCT06457295
Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography
An observational study of Diabetic Retinopathy, DR, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy, DR
- What is being tested?
- optical coherence tomography angiography
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2024to 1 Sep 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients will be recruited from diabetics who will present for retinopathy screening examination at outpatient clinic of Sohag University Hospital.
Who may be able to join
- Type of DM: Type 2.
- Fundus examination: no macular edema or other signs of clinical retinopathy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- optical coherence tomography angiography
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography angiographyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| non-diabetic | patients who are above 40 years old and don't have diabetes Receives: Diagnostic Test: optical coherence tomography angiography | |
| diabetic (0-5y) | patients who are above 40 years old and have diabetes for less than 5 years Receives: Diagnostic Test: optical coherence tomography angiography | |
| diabetics (5-10y) | patients who are above 40 years old and have diabetes for 5-10 years Receives: Diagnostic Test: optical coherence tomography angiography | |
| diabetics (10y < ) | patients who are above 40 years old and have diabetes for more than 10 years Receives: Diagnostic Test: optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
FAZ metrics
FAZ area, FAZ perimeter \& FAZ flow density
Measured: baseline
Superficial Vessel Density
foveal, average parafoveal \& average perifoveal
Measured: baseline
Deep Vessel Density
foveal, average parafoveal, average perifoveal
Measured: baseline
SCP thickness
foveal, average parafoveal \& average perifoveal
Measured: baseline
DCP thickness
foveal, average parafoveal \& average perifoveal
Measured: baseline
Sectoral superficial vessel density
superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal \& temporal perifoveal
Measured: baseline
Sectoral deep vessel density
superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal \& temporal perifoveal
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start20 Dec 2024
- Primary completion1 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Retinopathy, DRStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdou Saeed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457295
- Sponsor's protocol ID
- Soh-Med-24-05-16MS
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32053551
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Diabetes Mellitus on Retinal Microvasculature in Patients Without Clinical Retinopathy Using Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT06457295
- Acronym / sponsor ID
- Soh-Med-24-05-16MS
- Conditions
- Diabetic Retinopathy, DR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 13 Jun 2024 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-diabetic | – | Diagnostic Test: optical coherence tomography angiographypatients who are above 40 years old and don't have diabetes |
| diabetic (0-5y) | – | Diagnostic Test: optical coherence tomography angiographypatients who are above 40 years old and have diabetes for less than 5 years |
| diabetics (5-10y) | – | Diagnostic Test: optical coherence tomography angiographypatients who are above 40 years old and have diabetes for 5-10 years |
| diabetics (10y < ) | – | Diagnostic Test: optical coherence tomography angiographypatients who are above 40 years old and have diabetes for more than 10 years |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients will be recruited from diabetics who will present for retinopathy screening examination at outpatient clinic of Sohag University Hospital.
Key inclusion criteria (2 listed)
- Type of DM: Type 2.
- Fundus examination: no macular edema or other signs of clinical retinopathy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| optical coherence tomography angiographyA 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. | Diagnostic test | diabetic (0-5y), diabetics (10y < ), diabetics (5-10y), non-diabetic |
Primary outcome
FAZ metrics
Time frame: baseline
FAZ area, FAZ perimeter \& FAZ flow density
Superficial Vessel Density
Time frame: baseline
foveal, average parafoveal \& average perifoveal
Deep Vessel Density
Time frame: baseline
foveal, average parafoveal, average perifoveal
SCP thickness
Time frame: baseline
foveal, average parafoveal \& average perifoveal
DCP thickness
Time frame: baseline
foveal, average parafoveal \& average perifoveal
Sectoral superficial vessel density
Time frame: baseline
superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal \& temporal perifoveal
Sectoral deep vessel density
Time frame: baseline
superior parafoveal, inferior parafoveal, nasal parafoveal, temporal parafoveal, superior perifoveal, inferior perifoveal, nasal perifoveal \& temporal perifoveal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 32053551Rao 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, DR, 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAZ metrics (time frame: baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06457295, which also lists 1 linked publication.
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 19 Dec 2025.