Fundus Oculi and Erectile Dysfunction

• Conditions: Erectile Dysfunction
• Interventions: Device: Dynamic Vessel Analyzer (DVA); Drug: Phosphodiesterase type 5 Inhibitor (PDE5I)

• Registration Number: NCT02845765
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-22
• Study First Posted: 2016-07-27
• Status Verified: 2019-07
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-22
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with erectile dysfunction	Phosphodiesterase type 5 Inhibitor (PDE5I)	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).
Subject healthy volunteers	Dynamic Vessel Analyzer (DVA)	Patients without erectile dysfunction or ocular disease. Patients will be examined with Dynamic Vessel Analyzer (DVA) at baseline
Patients with erectile dysfunction	Dynamic Vessel Analyzer (DVA)	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).

Primary Outcome Measures

Name	Time	Method
Static and dynamic retinal vessels diameter	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

Name	Time	Method
International Index of Erectile Function (IIEF) Questionnaire	After 6 month of therapy	Revaluation of the correlation between Erectile Dysfunction and Fundus Oculi vascularization after 6 month of therapy for ED.

Trial Locations

Locations (1)

Ospedale San Raffaele; 🇮🇹 Milan, MI, Italy