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

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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction Following Radical Prostatectomy
• Intervention / Treatment: Drug: Tadalafil 20 MG

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 Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • University of Naples "Federico II"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

The participans were older than 45 years with diagnosis of erectile dysfunction due to surgery of radical prostatectomy. They did not receive previous treatment before Tadalafil. They did not present any ophthalmological disease, diabetes, heart diseases and hypertension.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; Healthy controls without previous surgery of radical prostatectomy.
Patients undergoing Tadalafil; Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months	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.; Other Names: Cialis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): May 25, 2020
• Study Completion (ACTUAL): May 30, 2020

Study Registration Dates

• First Submitted: July 25, 2020
• First Submitted That Met QC Criteria: July 25, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 25, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: 1516/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No