Fundus Oculi and Erectile Dysfunction

San Donato Group (GSD)

Status: Unknown

Conditions: Erectile Dysfunction

Treatments: Drug: Phosphodiesterase type 5 Inhibitor (PDE5I); Device: Dynamic Vessel Analyzer (DVA)

Study type: Observational

Funder types: Other

Identifiers

NCT02845765

N.2015 FundusOculi_DE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Patients with erectile dysfunction

Description:

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).

Treatment:

Drug: Phosphodiesterase type 5 Inhibitor (PDE5I)

Device: Dynamic Vessel Analyzer (DVA)

Subject healthy volunteers

Description:

Patients without erectile dysfunction or ocular disease. Patients will be examined with Dynamic Vessel Analyzer (DVA) at baseline

Treatment:

Device: Dynamic Vessel Analyzer (DVA)