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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Erectile Dysfunction Following Radical Prostatectomy

Intervention / Treatment
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* Drug: Tadalafil 20 MG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing Tadalafil<br>Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months | Drug: Tadalafil 20 MG<br>* To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.<br>* Other names: Cialis;|
| Control Group<br>Healthy controls without previous surgery of radical prostatectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months | Changes 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 | More than 6 months |