Glycemic Control and Retinal Microvascular Changes in Type 2 Diabetes Mellitus Patients Without Clinical Retinopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Retinopathy
- Sponsor
- Seoul National University Hospital
- Enrollment
- 259
- Locations
- 1
- Primary Endpoint
- Retinal vessel density (VD, %)
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Retinal vessel density (VD, %)
Time Frame: 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)
Time Frame: 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)
Time Frame: Upon initial registration and through study completion, an average of 1 year
Retinal layer thickness were calculated automatically using the bundled software