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Fundus Oculi and Erectile Dysfunction

S

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)

Trial contacts and locations

1

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Central trial contact

Giuseppe Querques, MD, PhD; Roberta Scano

Data sourced from clinicaltrials.gov

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