Diabetic Retinopathy Clinical Trial
Official title:
Glycemic Control and Retinal Microvascular Changes in Type 2 Diabetes Mellitus Patients Without Clinical Retinopathy
Verified date | November 2023 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Dongguk University Ilsan Hospital | Goyang-si | Republic Of Korea |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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 |
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