Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy control | The controls included patients without DM who presented for regular ophthalmic examination. | ||
| intensive control (IC) group | The mean HbA1c level was calculated during the 12 months prior to the OCT and OCTA. Based on the mean HbA1c level, T2DM patients were divided into intensive control (IC; mean HbA1c ≤ 7.0%) and moderate control (MC; mean HbA1c > 7.0%) groups | ||
| moderate control (MC) group | The mean HbA1c level was calculated during the 12 months prior to the OCT and OCTA. Based on the mean HbA1c level, T2DM patients were divided into intensive control (IC; mean HbA1c ≤ 7.0%) and moderate control (MC; mean HbA1c > 7.0%) groups |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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. The controls included patients without DM who presented for regular ophthalmic examination. One eye each of DM patients and controls was included in the study. The eye without significant ocular disease was selected from both eyes; if both eyes were eligible, the right eye was selected. The participants underwent comprehensive ophthalmic examination, including best-corrected visual acuity assessment using the Snellen chart, slit-lamp biomicroscopy, dilated fundus examination, ultra-widefield fundus photography, spectrum-domain OCT, and SS-OCTA. Patients with T2DM were included in the study after a retinal specialist confirmed absence of signs of DR on clinical examination and ultra-wide fundus photography.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguk University Ilsan Hospital | Goyang-si | Republic of Korea | 10324 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D009410 | Nerve Degeneration |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |