We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05644548
Recruitment Status : Recruiting
First Posted : December 9, 2022
Last Update Posted : December 9, 2022
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Hypertension Diabetes Mellitus Dyslipidemias 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Retinal Vascular Manifestations in Patients With Common Internal Diseases on Optical Coherence Tomography Angiography
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Vascular density of the retina [ Time Frame: up to 5 years of follow-up. ]
    percent


Secondary Outcome Measures :
  1. the foveal avascular zone (FAZ) size of the retina [ Time Frame: When participating in the study, and once a year during 5 years of follow-up. ]
    mm2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05644548


Contacts
Layout table for location contacts
Contact: Yu He, MD +861058268320 bluelight323@126.com
Contact: Ma Jinbao, MD +861058268320 majinbao77@sina.com

Locations
Layout table for location information
China, Beijing
Beijing Tongren Hospital Recruiting
Beijing, Beijing, China
Contact: Yu He, MD    +86-010-58268320    bluelight323@126.com   
Sponsors and Collaborators
Beijing Tongren Hospital
Layout table for additonal information
Responsible Party: Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT05644548    
Other Study ID Numbers: YuHe2022
First Posted: December 9, 2022    Key Record Dates
Last Update Posted: December 9, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Tongren Hospital:
OCTA
Hypertension
Diabetes
Dyslipidemias
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Dyslipidemias
Vascular Diseases
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases