Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- GCL+ in the macular area obtained using the 3D wide mode
研究概览
简要总结
The object of this study is to investigate the damage to the retinal nerve fiber layer (RNFL) and ganglion cell complex layer (GCL+) in diabetic patients without retinal microangioma as detected by fundus fluorescein angiography (FFA) and to determine the kind of nerve damage more likely to indicate early injury.
详细描述
Patients with type 2 diabetes mellitus and healthy volunteers will be included in our study. Patients with retinal microangioma are excluded by FFA. The parameters around the optic disc and macular area of the above two groups are measured by optical coherence tomography (OCT), and the results will be analyzed using the SPSS 22.0 software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with T2DM
- •Patients without microangioma
排除标准
- •Patients with any other ocular disease that might affect retinal nerve injury
- •Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion.
- •Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes.
- •Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.
研究组 & 干预措施
T2DM Patients
Patients without microangioma changes undergoing FFA examination were included in the present study. All of the participants enrolled in the present study underwent a systematic ophthalmic examination.
干预措施: routine ophthalmic examination (Device)
healthy control subjects
All of the participants enrolled in the present study underwent a systematic ophthalmic examination.
干预措施: routine ophthalmic examination (Device)
结局指标
主要结局
GCL+ in the macular area obtained using the 3D wide mode
时间窗: 96 weeks
GCL+ in the macular area obtained using the 3D wide mode
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
时间窗: 96 weeks
RNFL thickness in the macular area obtained using the 3D Macula (v) mode
Peripapillary RNFL thickness
时间窗: 96 weeks
Peripapillary RNFL thickness
Retinal thickness in all macular regions
时间窗: 96 weeks
Retinal thickness in all macular regions
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
时间窗: 96 weeks
GCL+ thickness in the macular region obtained using the 3D Macula (v) mode
次要结局
未报告次要终点
研究者
Xiang Zhu
Professor
Third Affiliated Hospital, Sun Yat-Sen University