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

Sponsor
Mingzhe Cao (Other)
Overall Status
Recruiting
CT.gov ID
NCT05902650
Collaborator
(none)
200
Enrollment
1
Location
35.9
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: imaging

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 Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. fasting blood glucose (FBG) [the time of the patient's first 1 day visit]

    biochemical indexes

  2. glycosylated hemoglobin (HbAlc) [the time of the patient's first 1 day visit]

    biochemical indexes

  3. OCTA data [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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Seventh Affiliated Hospital, Sun Yat-sen University Shenzhen Guangdong China 518000

Sponsors and Collaborators

  • Mingzhe Cao

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mingzhe Cao, Attending ophthalmologist, The Seventh Affiliated Hospital of Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05902650
Other Study ID Numbers:
  • MCao
First Posted:
Jun 15, 2023
Last Update Posted:
Jun 15, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy

Study Results

No Results Posted as of Jun 15, 2023