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Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months

Evaluation of Retinal and Choriocapillary Vascular Changes Using Optical Coherence Tomography Angiography in Patients Undergoing Tadalafil 20mg on Alternative Days for More Than 6 Months: a Single-centre Prospective-control

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04491773
Enrollment
54
Registered
2020-07-29
Start date
2019-11-01
Completion date
2020-05-30
Last updated
2020-07-29

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 for more than 6 months, 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 noninvasive 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 features after the somministration of Tadalafil 20 mg orally for more than 6 months.

Interventions

To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
45 Years to 70 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 for more than 6 months * absence of diabetes, heart diseases, hypertension * absence of drug intake * absence of vitreoretinal, vascular retinal diseases * absence of previous ocular surgery and congenital eye diseases. * absence of errors of refraction * absence of lens opacities * absence of low-quality OCT and OCTA images

Exclusion criteria

* age younger than 45 years * diagnosis of erectile dysfunction due to other causes * previous treatments before Tadalafil for erectile dysfunction * presence of diabetes, heart diseases, hypertension * drug intake * vitreoretinal and vascular retinal diseases * previous ocular surgery and congenital eye diseases * errors of refraction * lens opacities * low-quality OCT and OCTA images

Design outcomes

Primary

MeasureTime frameDescription
The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 monthsMore than 6 monthsChanges in retinal and choriocapillary vessel density in patients after radical prostatectomy, undergoing Tadalafil 20 mg orally on alternate days for more than 6 months, 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