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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05902650
• Other study ID #: MCao
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: The Seventh Affiliated Hospital of Sun Yat-sen University
• Contact: Mingzhe Cao, Dr.
• Phone: 13060822790
• Email: zhengz[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Diagnostic Test:
• imaging
imaging

Locations

Country	Name	City	State
China	The Seventh Affiliated Hospital, Sun Yat-sen University	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Mingzhe Cao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fasting blood glucose (FBG)	biochemical indexes	the time of the patient's first 1 day visit
Primary	glycosylated hemoglobin (HbAlc)	biochemical indexes	the time of the patient's first 1 day visit
Primary	OCTA data	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