Glycemic Control and Retinal Microvascular Changes in Type 2 Diabetes Mellitus Patients Without Clinical Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 259
- 试验地点
- 1
- 主要终点
- Retinal vessel density (VD, %)
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Retinal vessel density (VD, %)
时间窗: 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)
时间窗: 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)
时间窗: Upon initial registration and through study completion, an average of 1 year
Retinal layer thickness were calculated automatically using the bundled software
次要结局
未报告次要终点