Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg

September 22, 2021 updated by: Gilda Cennamo, Federico II University

Evaluation of Retinal and Choriocapillary Vascular Changes Using Optical Coherence Tomography Angiography in Patients Undergoing Tadalafil 20mg on Alternative Days: a Single-centre Prospective-control

This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg using optical coherence tomography angiography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 non-invasive 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 parameters at baseline and after 1, 3, 6 months after the somministration of Tadalafil 20 mg orally.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 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 and they have not other ophthalmological disease and diabetes.

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
  • absence of vitreoretinal and vascular retinal diseases
  • absence of diabetes

Exclusion Criteria:

  • age younger than 45 years
  • diagnosis of erectile dysfunction due to other causes
  • previous treatments before Tadalafil for erectile dysfunction
  • presence of vitreoretinal and vascular retinal diseases
  • presence of diabetes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing Tadalafil
Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for 6 months
Drug: Tadalafil 20 MG
To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, at baseline and 1, 3, 6 months after radical prostatectomy
Other Names:
  • Cialis
Control Group
Healthy controls without previous surgery of radical prostatectomy.

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 after radical prostatectomy
Time Frame: Six months
Changes in retinal and choriocapilary vessel density in 40 patients undergoing Tadalafil 20 mg orally, on alternate days, at baseline and 1, 3, 6 months after radical prostatectomy, using optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2020

Primary Completion (Actual)

April 25, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT1515/19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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