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Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg

Evaluation of Retinal and Choriocapillary Vascular Changes Using Optical Coherence Tomography Angiography in Patients Undergoing Tadalafil 20mg on Alternative Days: a Single-centre Prospective-control

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04164355
Enrollment
40
Registered
2019-11-15
Start date
2020-07-04
Completion date
2021-04-30
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Brief summary

This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg using optical coherence tomography angiography.

Detailed description

Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood flow to the penis thus promoting the erection. This drug represents an treatment for erectile dysfunction in patients after radical prostatectomy. The optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features. The study evaluates the changes in optical coherence tomography angiography parameters at baseline and after 1, 3, 6 months after the somministration of Tadalafil 20 mg orally.

Interventions

To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, at baseline and 1, 3, 6 months after radical prostatectomy

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
45 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* age older than 45 years * diagnosis of erectile dysfunction due to surgery of radical prostatectomy * treatment-naïve with Tadalafil for erectile dysfunction * absence of vitreoretinal and vascular retinal diseases * absence of diabetes

Exclusion criteria

* age younger than 45 years * diagnosis of erectile dysfunction due to other causes * previous treatments before Tadalafil for erectile dysfunction * presence of vitreoretinal and vascular retinal diseases * presence of diabetes.

Design outcomes

Primary

MeasureTime frameDescription
The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil after radical prostatectomySix monthsChanges in retinal and choriocapilary vessel density in 40 patients undergoing Tadalafil 20 mg orally, on alternate days, at baseline and 1, 3, 6 months after radical prostatectomy, using optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026