Erectile DysfunctionNCT02845765
Fundus Oculi and Erectile Dysfunction
An observational study of Erectile Dysfunction, run by Ospedale San Raffaele at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Dynamic Vessel Analyzer (DVA) and Phosphodiesterase type 5 Inhibitor (PDE5I)
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: * n. 40 patients with erectile dysfunction haracterized by the inability to develop or maintain an erection of the penis during sexual activity * n. 20 subject healthy volunteers without erectile dysfunction or ocular desease
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele
Milan, MI, 20132
Giuseppe Querques, MD, PhD, +39 0226434004, giuseppe.querques@hotmail.it
Costantino Abbate, +39 0226435628, abbate.costantino@hsr.it
About this study
Official title: Evaluation of Vascularization of the Fundus Oculi in Patients With Erectile Dysfunction as Barometer of Patient's Health
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.
Read the detailed 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Dynamic Vessel Analyzer (DVA), Phosphodiesterase type 5 Inhibitor (PDE5I)
- Keywords
- Erectile Dysfunction, ED, Fundus Oculi, Retinal Vascularization, International Index of Erectile Function Questionnaire, IIEF, Dynamic Vessel Analyzer, DVA, Phosphodiesterase type 5 Inhibitor, PDE5Is
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Vessel Analyzer (DVA)Device
Phosphodiesterase type 5 Inhibitor (PDE5I)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Dynamic Vessel Analyzer (DVA); Drug: 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 Receives: Device: Dynamic Vessel Analyzer (DVA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 6 month of therapy
Secondary outcomes (1)
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.
Measured: After 6 month of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Querques Giuseppe, Ospedale San Raffaele
- Investigators
- Andrea Salonia, MD, PhD, Principal investigator, University Vita-Salute, San Raffaele Hospital - Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845765
- Sponsor's protocol ID
- N.2015 FundusOculi_DE
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2016
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vascularization of the Fundus Oculi in Patients With Erectile Dysfunction as Barometer of Patient's Health
- ClinicalTrials.gov ID
- NCT02845765
- Acronym / sponsor ID
- N.2015 FundusOculi_DE
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, ED, Fundus Oculi, Retinal Vascularization, International Index of Erectile Function Questionnaire, IIEF, Dynamic Vessel Analyzer, DVA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with erectile dysfunction | – | Device: Dynamic Vessel Analyzer (DVA), Drug: Phosphodiesterase type 5 Inhibitor (PDE5I)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 | – | Device: Dynamic Vessel Analyzer (DVA)Patients without erectile dysfunction or ocular disease. Patients will be examined with Dynamic Vessel Analyzer (DVA) at baseline |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * n. 40 patients with erectile dysfunction haracterized by the inability to develop or maintain an erection of the penis during sexual activity * n. 20 subject healthy volunteers without erectile dysfunction or ocular desease
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Vessel Analyzer (DVA) | Device | Patients with erectile dysfunction, Subject healthy volunteers |
| Phosphodiesterase type 5 Inhibitor (PDE5I) | Drug | Patients with erectile dysfunction |
Primary outcome
Static and dynamic retinal vessels diameter
Time frame: Baseline and after 6 month of therapy
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.
1 secondary outcome
International Index of Erectile Function (IIEF) Questionnaire
Time frame: After 6 month of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Erectile Dysfunction
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation
Recruiting
Concurrent Low Intensity Shockwave Therapy on Collagenase Clostridium Histolyticum for Peyronie's Disease
Peyronie Disease, Erectile Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Salonia, MD, PhD principal investigator
University Vita-Salute, San Raffaele Hospital - Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Querques, MD, PhD (+39 0226434004, giuseppe.querques@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static and dynamic retinal vessels diameter (time frame: Baseline and after 6 month of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.