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
Overview
- Phase
- Not Applicable
- Intervention
- Tadalafil 20 MG
- Conditions
- Erectile Dysfunction Following Radical Prostatectomy
- Sponsor
- Federico II University
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
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 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.
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 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
Exclusion Criteria
- •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
Arms & Interventions
Patients undergoing Tadalafil
Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months
Intervention: Tadalafil 20 MG
Outcomes
Primary Outcomes
The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months
Time Frame: 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