Multifocal Electro Retinogram Study of Hydroxy Chloroquine Retinopathy in Lupus Nephritis Patients: A Randomized Controlled Clinical Trial."
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Analysis of values of R1 or R2 amplitude or Ring Ratio
研究概览
简要总结
The aim of the study to assess the multifocal ERG (mfERG) changes in SLE patients treated with chloroquine in renal patients with comparison to SLE patients without kidney affection.
详细描述
Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory
disease that involves different organs and systems. The heterogeneous nature of
the disease represents a great challenge in its diagnosis and management.1 Studies
reported that the percentage of SLE patients demonstrating ocular manifestations
can reach up to 30%.2
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old.
- •Emmetropic patients with normal fundus.
- •Patients with SLE diagnosed by a rheumatologist with no ocular involvement upon clinical examination.
排除标准
- •Patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery.
- •Patients with significant media opacity as corneal opacity, cataract.
- •Patients with ocular diseases as glaucoma, uveitis.
- •Patients with systemic diseases as diabetes mellitus, hypertension.
结局指标
主要结局
Analysis of values of R1 or R2 amplitude or Ring Ratio
时间窗: 3 months
Abnormal values of R1 or R2 amplitude or Ring Ratio (R1 / R2, R1 / R3, R1 / R4, R1 / R5) in each of the patient's eyes as abnormal mfERG.
Analysis of mfERG parameters
时间窗: 3 months
Analysis of N1, P1, N2 in five concentric areas of the macula between the two groups.
次要结局
未报告次要终点
研究者
Mohamed Salah
Doctor
Minia University