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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05644548
• Other study ID #: YuHe2022
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2022
• Source: Beijing Tongren Hospital
• Contact: Yu He, MD
• Phone: +861058268320
• Email: bluelight323[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Dyslipidemias
• Hypertension

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular density of the retina	percent	up to 5 years of follow-up.
Secondary	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.