Glycemic Control and Retinal Microvascular Changes

Diabetic Retinopathy Clinical Trial

Official title:

Glycemic Control and Retinal Microvascular Changes in Type 2 Diabetes Mellitus Patients Without Clinical Retinopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06150495
• Other study ID #: IRB no. 2021-06-029
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this prospective, observational study is to compare in the association of glycemic control and retinal microvascular changes in patients with type 2 diabetes mellitus (T2DM) without diabetic retinopathy (DR).

The main question it aims to answer are:

• Do degenerative changes in retinal microvasculature or nerves depend on glycemic control even before diabetic retinopathy is detected?

Participants will receive an annual routine comprehensive examination including ultra-widefield fundus photography, spectral domain optical coherence tomography (OCT), and swept-source optical coherence tomography angiography (OCTA).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 259
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• The study included 30-70-year-old patients with T2DM without known DR at baseline who underwent regular screening for DR at the department of ophthalmology.

• Who underwent regular checkups for DR between January 2019 and August 2022 at Dongguk University Ilsan Hospital.

• The controls included patients without DM who presented for regular ophthalmic examination.

Exclusion Criteria:

• patients with a history of retinal or choroidal diseases (i.e., age-related macular degeneration, retinal vein occlusion, uveitis, retinal detachment, and central serous chorioretinopathy), glaucoma, or optic neuropathy

• patients with neurodegenerative diseases, such as Parkinson's disease and dementia.

Related Conditions & MeSH terms

• Blood Sugar; High
• Diabetic Retinopathy
• Hyperglycemia
• Nerve Degeneration
• Neurodegeneration
• Retinal Diseases

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang-si	Republic Of Korea

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The foveal avascular zone (FAZ) area (mm^2)	FAZ was defined as the avascular area in the foveal center.	Upon initial registration and through study completion, an average of 1 year
Primary	central foveal retinal thickness (um) and macular ganglion cell-inner plexiform layer (GC-IPL) thickness (um)	Retinal layer thickness were calculated automatically using the bundled software	Upon initial registration and through study completion, an average of 1 year
Primary	Retinal vessel density (VD, %)	The VD (%) was calculated using the following formula: VD (%) = vascular area (pixel) / (total area - FAZ area) (pixel) × 100.	Upon initial registration and through study completion, an average of 1 year