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NCT04164355 Clinical Trial

Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg

Erectile Dysfunction Following Radical Prostatectomy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04164355
Other study ID # PT1515/19
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 4, 2020
Est. completion date April 30, 2021

Study information
Verified date September 2021
Source Federico II University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg using optical coherence tomography angiography.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 30, 2021
Est. primary completion date April 25, 2021
Accepts healthy volunteers No
Gender Male
Age group 45 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tadalafil 20 MG
To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, at baseline and 1, 3, 6 months after radical prostatectomy

Locations
Country Name City State
Italy University of Naples "Federico II" Naples

Sponsors (1)
Lead Sponsor Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil after radical prostatectomy 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 Six months
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