Glycemic Control and Retinal Microvascular Changes

Active, not recruiting

• Conditions: Diabetic Retinopathy; Blood Sugar; High; Neurodegeneration

• Registration Number: NCT06150495
• Lead Sponsor: Seoul National University Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-08-31
• Status Verified: 2023-11
• Study First Submitted: 2023-11-12
• Study First Submitted QC: 2023-11-20
• Last Update Submitted: 2023-11-20
• Study First Posted: 2023-11-29
• Last Update Posted: 2023-11-29
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 259

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dongguk University Ilsan Hospital; 🇰🇷 Goyang-si, Republic Of Korea, Korea, Republic of