HypertensionNCT05644548
Retinal Vascular Manifestations in Patients With Common Internal Diseases on OCTA Tomography Angiography
An observational study of Hypertension and Diabetes Mellitus, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Hypertension, diabetes mellitus, and dyslipidemia are common internal diseases, and all diseases are atherosclerosis risk factors. Previous studies applied color fundus photography to analyze retinal vascular changes (including exudation, hemorrhage, neovascularization, etc.) in patients with hypertension or diabetes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Dyslipidemias
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Dec 2028
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the geriatric department of Beijing Tongren Hospital, China. Beijing Tongren Hospital is a third-class hospital.
Who may be able to join
- Patients with hypertension
- Or patients with diabetes
- Or patients with dyslipidemia
- Agree to participate in this study
Who cannot join
- Patients with malignant tumors
- Patients with autoimmune diseases
- Patients with immunodeficiency disease
- Disagree to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality
Yu He, MD, +86-010-58268320, bluelight323@126.com
About this study
Official title: Retinal Vascular Manifestations in Patients With Common Internal Diseases on Optical Coherence Tomography Angiography
Hypertension, diabetes mellitus, and dyslipidemia are common internal diseases, and all diseases are atherosclerosis risk factors. Previous studies applied color fundus photography to analyze retinal vascular changes (including exudation, hemorrhage, neovascularization, etc.) in patients with hypertension or diabetes, but the examination results could not be quantified.
This study intends to apply optical coherence tomography angiography (OCTA) to examine retinal vessels. This method has the following advantages: 1) It can quantify vascular changes, and 2) It is noninvasive and reproducible for patients' follow-up.
This study was designed to investigate retinal vascular changes in patients with hypertension, diabetes, and dyslipidemia on OCTA. We will collect the patients' general information (gender, age), comorbidities, medications, blood lipids, blood glucose, carotid ultrasound, ankle-brachial index, ambulatory blood pressure monitoring, color fundus photography, and OCTA results. We will follow up with the patients for five years and conduct the mentioned examinations once a year. We will also investigate the correlation between systemic atherosclerosis (such as coronary artery stenosis, and carotid artery stenosis) and retinal vasculopathy in patients with these diseases.
Read the detailed description
Patients with hypertension, diabetes mellitus, or dyslipidemia, who go to the department of geriatric medicine, Beijing Tongren Hospital from March 2022 to December 2023 will be included. We will collect general information, comorbidities, medication, laboratory tests, and examination results. These patients will be followed up for 5 years with a yearly collection of comorbidities, medication, laboratory tests, and examination results.
- Conditions
- Hypertension, Diabetes Mellitus, Dyslipidemias
- Being tested
- No intervention
- Keywords
- OCTA, Hypertension, Diabetes, Dyslipidemias
- Medical subject headings
- Hypertension, Diabetes Mellitus, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Hypertension | No intervention Receives: Other: No intervention | |
| Diabetes mellitus | No intervention Receives: Other: No intervention | |
| Dyslipidemia | No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular density of the retina
percent
Measured: up to 5 years of follow-up.
Secondary outcomes (1)
the foveal avascular zone (FAZ) size of the retina
mm2
Measured: When participating in the study, and once a year during 5 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe 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
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644548
- Sponsor's protocol ID
- YuHe2022
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma JB, Qin MZ, Cao K, Zhang YP, Guo CX. Control of blood pressure and blood glucose levels has important clinical significance to the retina. BMC Ophthalmol. 2025 Jul 1;25(1):368. doi: 10.1186/s12886-025-04164-y.
PubMed 40597972He Y, Qin MZ, Cao K, Zhang YP, Jiao X, Zhang Z, Wang GH, Liu Q, Liu Q, Ma JB, Jiang X, Guo CX. Assessment of the impact of low-density lipoprotein cholesterol on retinal vessels using optical coherence tomography angiography. Lipids Health Dis. 2024 Sep 16;23(1):301. doi: 10.1186/s12944-024-02287-7.
PubMed 39285295
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Vascular Manifestations in Patients With Common Internal Diseases on Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT05644548
- Acronym / sponsor ID
- YuHe2022
- Conditions
- Hypertension, Diabetes Mellitus, Dyslipidemias
- Keywords
- OCTA, Hypertension, Diabetes, Dyslipidemias
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Dec 2022 (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.
Hypertension, diabetes mellitus, and dyslipidemia are common internal diseases, and all diseases are atherosclerosis risk factors. Previous studies applied color fundus photography to analyze retinal vascular changes (including exudation, hemorrhage, neovascularization, etc.) in patients with hypertension or diabetes, but the examination results could not be quantified.
This study intends to apply optical coherence tomography angiography (OCTA) to examine retinal vessels. This method has the following advantages: 1) It can quantify vascular changes, and 2) It is noninvasive and reproducible for patients' follow-up.
This study was designed to investigate retinal vascular changes in patients with hypertension, diabetes, and dyslipidemia on OCTA. We will collect the patients' general information (gender, age), comorbidities, medications, blood lipids, blood glucose, carotid ultrasound, ankle-brachial index, ambulatory blood pressure monitoring, color fundus photography, and OCTA results. We will follow up with the patients for five years and conduct the mentioned examinations once a year. We will also investigate the correlation between systemic atherosclerosis (such as coronary artery stenosis, and carotid artery stenosis) and retinal vasculopathy in patients with these diseases.
Detailed description
Patients with hypertension, diabetes mellitus, or dyslipidemia, who go to the department of geriatric medicine, Beijing Tongren Hospital from March 2022 to December 2023 will be included. We will collect general information, comorbidities, medication, laboratory tests, and examination results. These patients will be followed up for 5 years with a yearly collection of comorbidities, medication, laboratory tests, and examination results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypertension | – | Other: No interventionNo intervention |
| Diabetes mellitus | – | Other: No interventionNo intervention |
| Dyslipidemia | – | Other: No interventionNo intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the geriatric department of Beijing Tongren Hospital, China. Beijing Tongren Hospital is a third-class hospital.
Key inclusion criteria (4 listed)
- Patients with hypertension
- Or patients with diabetes
- Or patients with dyslipidemia
- Agree to participate in this study
Key exclusion criteria (4 listed)
- Patients with malignant tumors
- Patients with autoimmune diseases
- Patients with immunodeficiency disease
- Disagree to participate in this study
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 |
|---|---|---|
| No interventionNo intervention | Other | Diabetes mellitus, Dyslipidemia, Hypertension |
Primary outcome
Vascular density of the retina
Time frame: up to 5 years of follow-up.
percent
1 secondary outcome
the foveal avascular zone (FAZ) size of the retina
Time frame: When participating in the study, and once a year during 5 years of follow-up.
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 25 Sep 2025.
- Derived from this study: PubMed 40597972Ma JB, Qin MZ, Cao K, Zhang YP, Guo CX. Control of blood pressure and blood glucose levels has important clinical significance to the retina. BMC Ophthalmol. 2025 Jul 1;25(1):368. doi: 10.1186/s12886-025-04164-y.
- Derived from this study: PubMed 39285295He Y, Qin MZ, Cao K, Zhang YP, Jiao X, Zhang Z, Wang GH, Liu Q, Liu Q, Ma JB, Jiang X, Guo CX. Assessment of the impact of low-density lipoprotein cholesterol on retinal vessels using optical coherence tomography angiography. Lipids Health Dis. 2024 Sep 16;23(1):301. doi: 10.1186/s12944-024-02287-7.
- 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.
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 Hypertension and Diabetes Mellitus, run by Beijing Tongren Hospital at 1 site in China.
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 4 inclusion and 4 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 25 Sep 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 China. 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 Yu He, MD (+861058268320, bluelight323@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular density of the retina (time frame: up to 5 years of follow-up.). 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 NCT05644548, which also lists 2 linked publications.
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 25 Sep 2025.