Evaluation of Retinal and Choriocapillary Vascular Changes Using Optical Coherence Tomography Angiography in Patients Undergoing Tadalafil 20mg on Alternative Days: a Single-centre Prospective-control
Overview
- Phase
- Not Applicable
- Intervention
- Tadalafil 20 MG
- Conditions
- Erectile Dysfunction Following Radical Prostatectomy
- Sponsor
- Federico II University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil after radical prostatectomy
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg using optical coherence tomography angiography.
Detailed Description
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 non-invasive 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 parameters at baseline and after 1, 3, 6 months after the somministration of Tadalafil 20 mg orally.
Investigators
Gilda Cennamo
Principal Investigator
Federico II University
Eligibility Criteria
Inclusion Criteria
- •age older than 45 years
- •diagnosis of erectile dysfunction due to surgery of radical prostatectomy
- •treatment-naïve with Tadalafil for erectile dysfunction
- •absence of vitreoretinal and vascular retinal diseases
- •absence of diabetes
Exclusion Criteria
- •age younger than 45 years
- •diagnosis of erectile dysfunction due to other causes
- •previous treatments before Tadalafil for erectile dysfunction
- •presence of vitreoretinal and vascular retinal diseases
- •presence of diabetes.
Arms & Interventions
Patients undergoing Tadalafil
Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for 6 months
Intervention: Tadalafil 20 MG
Outcomes
Primary Outcomes
The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil after radical prostatectomy
Time Frame: Six months
Changes in retinal and choriocapilary vessel density in 40 patients undergoing Tadalafil 20 mg orally, on alternate days, at baseline and 1, 3, 6 months after radical prostatectomy, using optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density