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
