Fundus Oculi and Erectile Dysfunction

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: Erectile Dysfunction
• Intervention / Treatment: 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
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Giuseppe Querques, MD, PhD; Phone Number: +39 0226434004; Email: giuseppe.querques@hotmail.it
• Study Contact Backup: Name: Roberta Scano; Phone Number: +39 0226435506; Email: scano.roberta@hsr.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20132
      • Recruiting
      • Ospedale San Raffaele
      • Contact: Giuseppe Querques, MD, PhD; Phone Number: +39 0226434004; Email: giuseppe.querques@hotmail.it
      • Contact: Costantino Abbate; Phone Number: +39 0226435628; Email: abbate.costantino@hsr.it
      • Principal Investigator: Andrea Salonia, MD, PhD

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	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	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

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

Study record dates

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: ED; Erectile Dysfunction; IIEF; Fundus Oculi; Retinal Vascularization; International Index of Erectile Function Questionnaire; Dynamic Vessel Analyzer; DVA; Phosphodiesterase type 5 Inhibitor; PDE5Is
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors
• Other Study ID Numbers: N.2015 FundusOculi_DE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED