Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy
1 other identifier
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 15, 2023
June 1, 2023
3 years
June 1, 2023
June 13, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
fasting blood glucose (FBG)
biochemical indexes
the time of the patient's first 1 day visit
glycosylated hemoglobin (HbAlc)
biochemical indexes
the time of the patient's first 1 day visit
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
Study Arms (4)
Group 1
diabetic patients with no diabetic retinopathy
Group 2
diabetic patients with mild nonproliferative diabetic retinopathy
Group 3
diabetic patients with moderate and severe nonproliferative diabetic retinopathy
Group 4
diabetic patients with proliferative diabetic retinopathy
Interventions
Eligibility Criteria
diabetic patients
You may qualify if:
- Clinical diagnosis of diabetes
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mingzhe Caolead
Study Sites (1)
The Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mingzhe Cao
The Seventh Affiliated Hospital of Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending ophthalmologist
Study Record Dates
First Submitted
June 1, 2023
First Posted
June 15, 2023
Study Start
January 1, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
June 15, 2023
Record last verified: 2023-06