Fundus Oculi and Erectile Dysfunction

July 20, 2020 updated by: Querques Giuseppe, Ospedale San Raffaele

Evaluation of Vascularization of the Fundus Oculi in Patients With Erectile Dysfunction as Barometer of Patient's Health

The purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ED.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the correlation between fundus oculi's vascularization in patients with erectile dysfunction and not, and, in the same patients, before and after using drugs for ED.

In this monocentric, prospective, observational case-control study 40 eyes of 40 patients affected by erectile dysfunction and 20 healthy age-matched controls will be enrolled.

Patients will undergo DVA examination at baseline and 6 months after PDE5I therapy. Healthy subjects will be examined with DVA at baseline only.

Study Type

Observational

Enrollment (Anticipated)

60

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
    • MI
      • Milan, MI, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrea Salonia, MD, PhD

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

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

  • n. 40 patients with erectile dysfunction haracterized by the inability to develop or maintain an erection of the penis during sexual activity
  • n. 20 subject healthy volunteers without erectile dysfunction or ocular desease

Description

Inclusion Criteria:

  • Subjects with erectile dysfunction diagnosis (organic and psychogenic);
  • Subjects with Erectile Dysfunction diagnosis defined by IIEF score ≤ 25
  • Subjects with stable partner for at least 6 months and sexually active.
  • Subjects aged between 40 - 60 years;
  • Signature of informed consent for patients

Exclusion Criteria:

  • Subjects with ED secondary diagnosis to hormonal alterations (i.e. hypogonadism, hypo / hyperthyroidism, hyperprolactinemia);
  • Subjects with a diagnosis of ED post-traumatic and iatrogenic, since after pelvic surgery;
  • Subjects suffering from any ocular pathology that involves use of contact lenses and / or glasses;
  • Subjects smoking;
  • Individuals with uncontrolled systemic diseases;
  • All persons who do not confirm at least one criterion for inclusion.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with erectile dysfunction
Patients with erectile dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual activity. Patients will be examined with Dynamic Vessel Analyzer (DVA) at baseline and 6 months after therapy with Phosphodiesterase type 5 Inhibitor (PDE5I).
Device: Dynamic Vessel Analyzer (DVA)
Drug: Phosphodiesterase type 5 Inhibitor (PDE5I)
Subject healthy volunteers
Patients without erectile dysfunction or ocular disease. Patients will be examined with Dynamic Vessel Analyzer (DVA) at baseline
Device: Dynamic Vessel Analyzer (DVA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static and dynamic retinal vessels diameter
Time Frame: Baseline and after 6 month of therapy
Analysis of the presence and prevalence of retinal vascularization alterations using Dynamic Vessel Analyzer (DVA) in patients with Erectile Dysfunction and in subject healthy volunteers.
Baseline and after 6 month of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Index of Erectile Function (IIEF) Questionnaire
Time Frame: After 6 month of therapy
Revaluation of the correlation between Erectile Dysfunction and Fundus Oculi vascularization after 6 month of therapy for ED.
After 6 month of therapy

Collaborators and Investigators

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

Sponsor

Ospedale San Raffaele

Investigators

  • Principal Investigator: Andrea Salonia, MD, PhD, University Vita-Salute, San Raffaele Hospital - Milan

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

February 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (ESTIMATE)

July 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N.2015 FundusOculi_DE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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