Status:
COMPLETED
Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months
Lead Sponsor:
Federico II University
Conditions:
Erectile Dysfunction Following Radical Prostatectomy
Eligibility:
MALE
45-70 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04491773
Start Date
November 1 2019
End Date
May 30 2020
Last Update
July 29 2020
Active Locations (1)
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1
University of Naples "Federico II"
Naples, Italy, 80100