Fundus Oculi and Erectile Dysfunction

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Vascularization of the Fundus Oculi in Patients With Erectile Dysfunction as Barometer of Patient's Health

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Device: Dynamic Vessel Analyzer (DVA)
* Drug: Phosphodiesterase type 5 Inhibitor (PDE5I)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with erectile dysfunction<br>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)<br> <br> Drug: Phosphodiesterase type 5 Inhibitor (PDE5I)<br> <br> |
| Subject healthy volunteers<br>Patients without erectile dysfunction or ocular disease. Patients will be examined with Dynamic Vessel Analyzer (DVA) at baseline | Device: Dynamic Vessel Analyzer (DVA)<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, ED, Fundus Oculi, Retinal Vascularization, International Index of Erectile Function Questionnaire, IIEF, Dynamic Vessel Analyzer, DVA, Phosphodiesterase type 5 Inhibitor, PDE5Is