Clinical trial NCT05644548: Retinal Vascular Manifestations in Patients With Common Internal Diseases on OCTA Tomography Angiography
Official title: Retinal Vascular Manifestations in Patients With Common Internal Diseases on Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Diabetes Mellitus
Dyslipidemias
Keywords: OCTA
Hypertension
Diabetes
Dyslipidemias
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the geriatric department of Beijing Tongren Hospital, China. Beijing Tongren Hospital is a third-class 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.

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

Primary outcomes:
measure: Vascular density of the retina
timeFrame: up to 5 years of follow-up.
Secondary outcomes:
measure: the foveal avascular zone (FAZ) size of the retina
timeFrame: When participating in the study, and once a year during 5 years of follow-up.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
References: