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Fundus Oculi and Erectile Dysfunction

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ClinicalTrials.gov Identifier: NCT02845765
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Querques Giuseppe, Ospedale San Raffaele

Brief Summary:
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.

Condition or disease Intervention/treatment
Erectile Dysfunction Device: Dynamic Vessel Analyzer (DVA) Drug: Phosphodiesterase type 5 Inhibitor (PDE5I)

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
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Vascularization of the Fundus Oculi in Patients With Erectile Dysfunction as Barometer of Patient's Health
Study Start Date : February 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845765


Contacts
Contact: Giuseppe Querques, MD, PhD +39 0226434004 giuseppe.querques@hotmail.it
Contact: Roberta Scano +39 0226435506 scano.roberta@hsr.it

Locations
Italy
Ospedale San Raffaele Recruiting
Milan, MI, Italy, 20132
Contact: Giuseppe Querques, MD, PhD    +39 0226434004    giuseppe.querques@hotmail.it   
Contact: Costantino Abbate    +39 0226435628    abbate.costantino@hsr.it   
Principal Investigator: Andrea Salonia, MD, PhD         
Sponsors and Collaborators
Ospedale San Raffaele
Investigators
Principal Investigator: Andrea Salonia, MD, PhD University Vita-Salute, San Raffaele Hospital - Milan

Responsible Party: Querques Giuseppe, Head-Medical retina & Imaging unit, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT02845765     History of Changes
Other Study ID Numbers: N.2015 FundusOculi_DE
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Querques Giuseppe, Ospedale San Raffaele:
Erectile Dysfunction
ED
Fundus Oculi
Retinal Vascularization
International Index of Erectile Function Questionnaire
IIEF
Dynamic Vessel Analyzer
DVA
Phosphodiesterase type 5 Inhibitor
PDE5Is

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Glucuronyl glucosamine glycan sulfate
Phosphodiesterase 5 Inhibitors
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors