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

Sponsor
Beijing Tongren Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05644548
Collaborator
(none)
300
1
82
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Retinal Vascular Manifestations in Patients With Common Internal Diseases on Optical Coherence Tomography Angiography
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Hypertension

No intervention

Other: No intervention
No intervention

Diabetes mellitus

No intervention

Other: No intervention
No intervention

Dyslipidemia

No intervention

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. Vascular density of the retina [up to 5 years of follow-up.]

    percent

Secondary Outcome Measures

  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.]

    mm2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tongren Hospital Beijing Beijing China

Sponsors and Collaborators

  • Beijing Tongren Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing Tongren Hospital
ClinicalTrials.gov Identifier:
NCT05644548
Other Study ID Numbers:
  • YuHe2022
First Posted:
Dec 9, 2022
Last Update Posted:
Dec 9, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beijing Tongren Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2022