Retinal Vascular Manifestations in Patients With Common I... | NCT05644548

Studies
Retinal Vascular Manifestations in Patients With Common Internal Diseases on OCTA Tomography Angiography

NCT05644548

Sponsor

Beijing Tongren Hospital

Status

Recruiting

Last Update Posted

Sep 25, 2025Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Hypertension
Diabetes Mellitus
Dyslipidemias

Interventions

No intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Dec 1, 2022

First Submission Date that Met QC Criteria

Dec 8, 2022

First Posted Date

Dec 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2025

Last Update Posted Date

Sep 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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, 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Hypertension	No intervention	Other: No intervention
Diabetes mellitus	No intervention	Other: No intervention
Dyslipidemia	No intervention	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	Diabetes mellitus Dyslipidemia Hypertension

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vascular density of the retina	percent	up to 5 years of follow-up.

Secondary Outcomes

Measure	Description	Time Frame
the foveal avascular zone (FAZ) size of the retina	mm2	When participating in the study, and once a year during 5 years of follow-up.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with hypertension
Or patients with diabetes
Or patients with dyslipidemia
Agree to participate in this study

Exclusion Criteria:

Patients with malignant tumors
Patients with autoimmune diseases
Patients with immunodeficiency disease
Disagree to participate in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients in the geriatric department of Beijing Tongren Hospital, China. Beijing Tongren Hospital is a third-class hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu He, MD	Contact	+861058268320		bluelight323@126.com
Ma Jinbao, MD	Contact	+861058268320		majinbao77@sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tongren Hospital	Recruiting	Beijing	Beijing Municipality		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40597972	Derived	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.
39285295	Derived	He 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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
D006973	Hypertension
D003920	Diabetes Mellitus
D050171	Dyslipidemias