Effect of Intravitreal and Intracameral Injection of Dexamethasone Sodium Phosphate on Mild to Moderate NPDR During Cataract Phacoemulsification
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- measure the central point thickness (CPT) and central foveal thickness (CFT)
研究概览
简要总结
To investigate the effects of intravitreal and intracameral injection of dexamethasone during cataract phacoemulsification in patients with mild to moderate non-proliferative diabetic retinopathy
详细描述
The study aims to analyze the impact of intravitreal and intracameral DEX in diabetic patients with NPDR who are undergoing phacoemulsification surgery. Specifically, the investigators will investigate its effects on postoperative macular central thickness, the development of DME, and the progression of DR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetic cataracts patients who were diagnosed with mild to moderate NPDR
排除标准
- 未提供
研究组 & 干预措施
intravitreal DEX group
Patients received an intravitreal injection of 0.5 mg DEX during phacoemulsification in the intravitreal DEX group
干预措施: Dexamethasone sodium phosphate (Drug)
intracameral DEX group
Patients received an intracameral injection of 0.5 mg DEX during phacoemulsification in the intracameral DEX group
干预措施: Dexamethasone sodium phosphate (Drug)
结局指标
主要结局
measure the central point thickness (CPT) and central foveal thickness (CFT)
时间窗: From enrollment to the end of treatment at 3 months
optical coherence tomography (OCT) was used to perform the retinal examination, macular cube scans (512 × 128) and measure the central point thickness (CPT) and central foveal thickness (CFT). The CPT measurement focused on a central circle with a diameter of 1mm, and the CFT was calculated as the average of three consecutive measurements
次要结局
未报告次要终点