Fundus Oculi and Erectile Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with erectile dysfunction

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).

Dynamic Vessel Analyzer (DVA)

Intervention Type DEVICE

Phosphodiesterase type 5 Inhibitor (PDE5I)

Intervention Type DRUG

Subject healthy volunteers

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

Dynamic Vessel Analyzer (DVA)

Intervention Type DEVICE

Interventions

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Dynamic Vessel Analyzer (DVA)

Intervention Type DEVICE

Phosphodiesterase type 5 Inhibitor (PDE5I)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes