Role OF OCT-A TO Detect Possible Retinal Vascular Complications of Sofosbuvir (Sovaldi) in Patients With Hepatitis C Virus Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment percentage of change in macular vessels density using OCTA
研究概览
简要总结
The purpose of this study is to prospectively evaluate the value of Optical coherence tomography angiography (OCT-A) for the of detection of suspected retinal complications With Sofosbuvir (Sovaldi) in Patients With Hepatitis C Virus Infection
详细描述
During 3 months duration ( the treatment course duration) , Optical coherence tomography angiography (OCT-A) will be performed to 30 eyes of 30 patients with a documented diagnosis of chronic hepatitis C before and after receiving dual-therapy planning (Daclatasvir - Sofosbuvir (Sovaldi)) , normal renal functions And Rheumatoid factor tests , will undergo a comprehensive ophthalmic examination including:
- Manifest refraction
- Corrected distance visual acuity
- Anterior segment examination using slit lamp and tear film breakup time test
- Fundus examination
Recent Optical coherence tomography angiography (OCT-A) will be performed to all patients before Treatment Administration.
Examination will be performed using "Optovue AngioVue®" "Optovue, Inc., Fremont, CA", which uses split-spectrum amplitude-decorrelation angiography algorithm, which minimizes motion noise. This system also allows quantitative analysis, since it provides numerical data about flow area and flow density maps.
The patient will be examined before and after finishing the treatment course
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 80 years.
- •Patients with chronic hepatitis C enrolled for (Daclatasvir - Sofosbuvir (Sovaldi)) .
- •Patients who have normal ocular and fundoscopic examination before the onset of treatment.
排除标准
- •Relapsed cases who have formerly taken the antiviral therapy (depending on the basis of medical record and filing system), or treated with interferon for any other cause .
- •Patients with elevated renal functions or positive Rheumatoid factor (as a clue to diagnose Purtscher like retinopathy which is a rare presentation of cryoglobulinemia ,considered one of extra hepatic manifestations of HCV )
研究组 & 干预措施
Sovaldi group
patients with a documented diagnosis of chronic hepatitis C , normal renal functions And Rheumatoid factor tests (to exclude Purtscher like retinopathy as a rare presentation of cryoglobuinemia which considered one of extra hepatic manifestations of HCV)
干预措施: Optical coherence tomography angiography (Device)
Sovaldi group
patients with a documented diagnosis of chronic hepatitis C , normal renal functions And Rheumatoid factor tests (to exclude Purtscher like retinopathy as a rare presentation of cryoglobuinemia which considered one of extra hepatic manifestations of HCV)
干预措施: Sofosbuvir (Sovaldi) (Drug)
结局指标
主要结局
Assessment percentage of change in macular vessels density using OCTA
时间窗: 3 months
Evaluate the suspected retinal vascular complications With Sofosbuvir (Sovaldi) ) in Patients With Hepatitis C Virus Infection, All results will be in numerical values (percentage) to compare retinal vascularity before and after using the drug..
visual acuity changes with Sofosbuvir
时间窗: 3 months
Comparing best corrected visual acuity (in values from o.o5 to 1.0) before and after drug administration .
次要结局
- amount of ocular dryness with Sofosbuvir using tear up breaking test(3 months)
- Role of Optical coherence tomography angiography (OCTA) in detection early signs retinopathy depending on changes in vascular density(3 months)
- amount of ocular dryness with Sofosbuvir using Schirmer's(3 months)
研究者
Mohamed Saad
Resident of Ophthalmology , Cairo University - researcher
Cairo University