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

Recruiting

• Conditions: Hypertension; Diabetes Mellitus; Dyslipidemias
• Interventions: Other: No intervention

• Registration Number: NCT05644548
• Lead Sponsor: Beijing Tongren Hospital

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.

Study Timeline

• Study Start: 2022-03-01
• Status Verified: 2022-11
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-08
• Last Update Submitted: 2022-12-08
• Study First Posted: 2022-12-09
• Last Update Posted: 2022-12-09
• Primary Completion: 2023-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetes mellitus	No intervention	No intervention
Hypertension	No intervention	No intervention
Dyslipidemia	No intervention	No intervention

Primary Outcome Measures

Name	Time	Method
Vascular density of the retina	up to 5 years of follow-up.	percent

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China