Study Overview

Details

NCTId: NCT02845765

Status: Recruiting

Condition: Erectile Dysfunction

Study Type: Observational

Sponsor: Ospedale San Raffaele

Study Description

Brief

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

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.

Eligibility

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.

Healthy Volunteers: Accepts Healthy Volunteers

Gender: Male

Min Age: 40 Years

Max Age: 60 Years

Contacts

Ospedale San Raffaele

Recruiting

Milan

MI

20132

Italy

Andrea Salonia, MD, PhD

Principal Investigator

+39 0226435628

abbate.costantino@hsr.it

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