Evaluation of Retinal and Choriocapillary Vascular Changes Using Optical Coherence Tomography Angiography in Patients Undergoing Tadalafil 20mg on Alternative Days for More Than 6 Months: a Single-centre Prospective-control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months
研究概览
简要总结
This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg for more than 6 months, using optical coherence tomography angiography.
详细描述
Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood flow to the penis thus promoting the erection.
This drug represents an treatment for erectile dysfunction in patients after radical prostatectomy.
The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.
The study evaluates the changes in optical coherence tomography angiography features after the somministration of Tadalafil 20 mg orally for more than 6 months.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age older than 45 years
- •diagnosis of erectile dysfunction due to surgery of radical prostatectomy
- •treatment-naïve with Tadalafil for erectile dysfunction for more than 6 months
- •absence of diabetes, heart diseases, hypertension
- •absence of drug intake
- •absence of vitreoretinal, vascular retinal diseases
- •absence of previous ocular surgery and congenital eye diseases.
- •absence of errors of refraction
- •absence of lens opacities
- •absence of low-quality OCT and OCTA images
排除标准
- •age younger than 45 years
- •diagnosis of erectile dysfunction due to other causes
- •previous treatments before Tadalafil for erectile dysfunction
- •presence of diabetes, heart diseases, hypertension
- •drug intake
- •vitreoretinal and vascular retinal diseases
- •previous ocular surgery and congenital eye diseases
- •errors of refraction
- •lens opacities
- •low-quality OCT and OCTA images
研究组 & 干预措施
Patients undergoing Tadalafil
Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months
干预措施: Tadalafil 20 MG (Drug)
结局指标
主要结局
The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months
时间窗: More than 6 months
Changes in retinal and choriocapillary vessel density in patients after radical prostatectomy, undergoing Tadalafil 20 mg orally on alternate days for more than 6 months, using optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density
次要结局
未报告次要终点
研究者
Gilda Cennamo
Principal Investigator
Federico II University