Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months

Completed

• Conditions: Erectile Dysfunction Following Radical Prostatectomy
• Interventions: Drug: Tadalafil 20 MG

• Registration Number: NCT04491773
• Lead Sponsor: Federico II University

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.

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-01
• Primary Completion: 2020-05-25
• Study Completion: 2020-05-30
• Study First Submitted: 2020-07-25
• Study First Submitted QC: 2020-07-25
• Last Update Submitted: 2020-07-25
• Study First Posted: 2020-07-29
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing Tadalafil	Tadalafil 20 MG	Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months

Primary Outcome Measures

Name	Time	Method
The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months	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

Trial Locations

Locations (1)

University of Naples "Federico II"; 🇮🇹 Naples, Italy