NCT05644548

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Mar 2022Dec 2028

Study Start

First participant enrolled

March 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

December 1, 2022

Last Update Submit

September 20, 2025

Conditions

HypertensionDiabetes MellitusDyslipidemias

Keywords

OCTAHypertensionDiabetesDyslipidemias

Outcome Measures

Primary Outcomes (1)

  • Vascular density of the retina

    percent

    up to 5 years of follow-up.

Secondary Outcomes (1)

  • the foveal avascular zone (FAZ) size of the retina

    When participating in the study, and once a year during 5 years of follow-up.

Study Arms (3)

Hypertension

No intervention

Other: No intervention

Diabetes mellitus

No intervention

Other: No intervention

Dyslipidemia

No intervention

Other: No intervention

Interventions

No interventionOTHER

No intervention

Diabetes mellitusDyslipidemiaHypertension

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40597972DERIVED

  • 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.

    PMID: 39285295DERIVED

MeSH Terms

Conditions

HypertensionDiabetes MellitusDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Central Study Contacts

Yu He, MD

CONTACT

+861058268320bluelight323@126.com

Ma Jinbao, MD

CONTACT

+861058268320majinbao77@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

March 1, 2022

Primary Completion

December 31, 2023

Study Completion (Estimated)

December 31, 2028

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)