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NCT Number: NCT04491773

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

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.

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Key information

Age range

45 year–70 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 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.

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 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

Treatment and study plan

Tadalafil 20 mg

Drug

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

Other names: Cialis

Primary outcomes

  1. The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months

    Time frame: 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

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2020
Registry last updated
Jul 29, 2020

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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