Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy

June 13, 2023 updated by: Mingzhe Cao
All OCTA data and biochemical indexes of diabetic patients were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Diabetic patients at the Department of Ophthalmology of the Seventh Affiliated Hospital of Sun Yat-sen University were selected as research participants. All OCTA data and biochemical indexes were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • The Seventh Affiliated Hospital, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

diabetic patients

Description

Inclusion Criteria:

  • Clinical diagnosis of diabetes

Exclusion Criteria:

  • various other types of retinal and choroidal disease;
  • history of any intraocular surgery or treatment (including intravitreal injection, retinal photocoagulation etc.
  • with severe refractive medium opacity that could affect fundus examination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
diabetic patients with no diabetic retinopathy
Diagnostic test: imaging
imaging
Group 2
diabetic patients with mild nonproliferative diabetic retinopathy
Diagnostic test: imaging
imaging
Group 3
diabetic patients with moderate and severe nonproliferative diabetic retinopathy
Diagnostic test: imaging
imaging
Group 4
diabetic patients with proliferative diabetic retinopathy
Diagnostic test: imaging
imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fasting blood glucose (FBG)
Time Frame: the time of the patient's first 1 day visit
biochemical indexes
the time of the patient's first 1 day visit
glycosylated hemoglobin (HbAlc)
Time Frame: the time of the patient's first 1 day visit
biochemical indexes
the time of the patient's first 1 day visit
OCTA data
Time Frame: the time of the patient's first 1 day visit
An image of the 3mm×3mm and 6 mm×6 mm macular areas detected by OCTA were captured. Quantitative analysis of vascular density and perfusion density of superficial capillary plexus in the macular area were automatically calculated using built-in software on the device.
the time of the patient's first 1 day visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mingzhe Cao

Investigators

  • Principal Investigator: Mingzhe Cao, The Seventh Affiliated Hospital of Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 13, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCao

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The research has not been completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Retinopathy

Clinical Trials on imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe