Posterior Segment Evaluation of Patients With Systemic Lupus Erythematosus Using Optical Coherence Tomography and Optical Coherence Tomography Angiography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Measurement of vessel density
研究概览
简要总结
Aim of The Study To evaluate different structural retinal changes using OCT and OCT-A in patients with SLE ; newly diagnosed patients and patients on treatment and compare parameters with normal subjects
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. Studies
reported that the percentage of SLE patients demonstrating ocular manifestations
can reach up to 30%.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years old.
- •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 and anti-glaucoma surgery.
- •Patients with significant media opacity as corneal opacity, cataract.
- •Patients with ocular diseases as glaucoma, uveitis.
- •Patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion.
- •Patients with systemic diseases as diabetes mellitus (DM), hypertension, abnormal kidney functions
结局指标
主要结局
Measurement of vessel density
时间窗: 3 months
comparison of vessel density of superficial and deep layers of retina in 150 subjects divided into 3 groups newly diagnosed SLE patients and SLE patients on treatment and normal subjects using OCT Angiography.
Measurement of foveal avascular zone
时间窗: 3 months
1) comparison of foveal avascular zone between 3 groups using OCT Angiography.
Measurement thickness of retinal nerve fiber layer
时间窗: 3 months
Comparison of thickness of retinal nerve fiber layer between the 3 groups using OCT.
Measurement of macular thickness
时间窗: 3 months
comparison of macular thickness between 3 groups using OCT.
Measurement of thickness of ganglion cell layer complex
时间窗: 3 months
Comparison of thickness of ganglion cell layer complex between the 3 groups using OCT.
次要结局
未报告次要终点
研究者
Hazem Mohamed Mohamed
Principal Investigator
Minia University