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

Federico II University54 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Interventions

Tadalafil 20 MGDRUG

To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.

Eligibility

Sex: MALEMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Naples "Federico II"

Naples, Italy

Outcomes

Primary Outcomes

The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for 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

Time frame: More than 6 months

Data from ClinicalTrials.gov

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