Choroidal and retinal alteration after long-term use of tadalafil: a prospective non-randomized clinical trial.

Objectives: The purpose of this study is to investigate choroidal and retinal vascular features in patients taking PDE5is by measuring dynamic vascular alterations and neurostructural features of the retina before and after oral tadalafil administration.

Methods: The current clinical research involved 22 patients treated with tadalafil 20 mg on alternate days (OAD) after nerve-sparing robotic radical prostatectomy (NS-RARP) for prostate cancer. Patients underwent SD-OCT to assess ganglion cell complex (GCC), retinal nerve fiber layer (RNFL), and subfoveal choroidal thickness (SFCT), as well as OCTA to assess superficial capillary plexus (SCP), deep capillary plexus (DCP), choriocapillaris (CC), foveal avascular zone (FAZ), and radial peripapillary capillary thickness (RPC). All patients were evaluated at baseline (t0), and 3 (t1) and 6 (t2) months after the use of oral tadalafil.

Results: A statistically significant reduction in DCP and CC vessel density was found at t2 compared to baseline. According to the SFCT parameter, a statistically significant increase was observed from t0 to t1, and from t1 to t2. GCC parameter increased at t2 compared to baseline in a statistically significant way. No statistically significant differences were recorded between t0, t1 and t2 for the SCP, RPC, FAZ area, RNFL parameter.

Conclusions: Retinal and optic disc toxicity may be detected using modifications of capillary vessel density. Further studies are needed to detect the possible progression or regression of ocular or systemic vascular complications in long-term follow-up.