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Completed

NCT Number: NCT04164355

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

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

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Key information

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Age range

45 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Naples "Federico II"

Naples, 80100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tadalafil 20 mg

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 15, 2019
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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