Fundus Oculi and Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02845765
• Other study ID #: N.2015 FundusOculi_DE
• Status: Recruiting
• Start date: February 2016
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: Ospedale San Raffaele
• Contact: Giuseppe Querques, MD, PhD
• Phone: +39 0226434004
• Email: giuseppe.querques[@]hotmail.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Dynamic Vessel Analyzer (DVA)

Drug:
• Phosphodiesterase type 5 Inhibitor (PDE5I)

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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