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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| Subject healthy volunteers | Patients without erectile dysfunction or ocular disease. Patients will be examined with Dynamic Vessel Analyzer (DVA) at baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Vessel Analyzer (DVA) | Device |
| ||
| Phosphodiesterase type 5 Inhibitor (PDE5I) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Querques, MD, PhD | Contact | +39 0226434004 | giuseppe.querques@hotmail.it | |
| Roberta Scano | Contact | +39 0226435506 | scano.roberta@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Salonia, MD, PhD | University Vita-Salute, San Raffaele Hospital - Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele | Recruiting | Milan | MI | 20132 | Italy |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D058986 | Phosphodiesterase 5 Inhibitors |
| ID | Term |
|---|---|
| D010726 | Phosphodiesterase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| Drug |
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D020164 | Chemical Actions and Uses |