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

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 for More Than 6 Months: a Single-centre Prospective-control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491773
• Other study ID #: 1516/19
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: November 2019
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 30, 2020
• Est. primary completion date: May 25, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 70 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 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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy

Intervention

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

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 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	More than 6 months