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

Federico II University

Status: Completed

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Treatments: Drug: Tadalafil 20 MG

Study type: Observational

Funder types: Other

Identifiers

NCT04491773

1516/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Male

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

54 participants in 2 patient groups

Patients undergoing Tadalafil

Description:

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

Treatment:

Drug: Tadalafil 20 MG

Control Group

Description:

Healthy controls without previous surgery of radical prostatectomy.