Benign Prostatic Hyperplasia Clinical Trial
Official title:
The Effects of Systemic Alfuzosin and Tamsulosin Hydrochloride on Choroidal Thickness and Pupil Diameter Sizes in Cases With Benign Prostatic Hyperplasia
It was aimed to evaluate and investigate the effects of tamsulosin hydrochloride, has
preferential selectivity for the α1A receptor in the prostat versus the α1B receptor in the
blood vessels, and alfuzosin hydrochloride on choroidal thickness (CT), pupil diameter sizes
evaluated by using enhanced depth imaging spectral-domain optical coherence tomography
(EDI-OCT) and scheimpflug/placido photography-based topoghraphy system in this study.
63 men patients with newly diagnosis of benign prostatic hyperplasia were randomly assigned
to either alfuzosin hydrochloride or to tamsulosin hydrochloride groups in this prospective,
randomized, parallel-group clinical trial. Enhanced depth imaging spectral-domain optical
coherence tomography, pupillography were obtained at baseline, 1st and 3rd month, and
choroidal thicknesses and pupil diameter sizes were compared between the 2 groups.
The local authorized clinical trials ethics committee approved the study and this study was
performed following the principles of the Declaration of Helsinki. Detailed information was
given to patients about clinical applications and tests, and signed informed consent forms
were also obtained from all patients. 32 right eyes of 32 men with diagnosis of BPH
initiated on AH (Xatral®) (10 mg/day) and 31 right eyes of 31 men with diagnosis of BPH
initiated on TH (Flomax®) (0.4 mg/day) were included in this self-controlled prospective
clinical trial. Urologists in the urology clinic made diagnosis of BPH, and 63 men diagnosis
of BPH were directed towards eye clinic. AH or TH treatments were randomly recommended for
previously untreated patients with newly diagnosis of BPH by urologists. After providing
information to patients about the disease and treatment, patients predicted to show
adherence to treatment, were enrolled in the study.
Ophthalmological examinations were performed in all cases. Choroidal thicknesses (CTs) were
measured under the fovea, 3 mm nasal to the fovea and 3 mm temporal to the fovea, and they
were recorded as submacular (SCT), nasal (NCT) and temporal (TCT) choroidal thicknesses. CTs
were measured and recorded by using EDI-OCT imaging (Cirrus HD 4000, Carl Zeis Meditec, CA,
USA). Mesopic, scotopic and photopic pupil diameter sizes were measured and recorded by
using Scheimpflug/Placido photography-based topography system in the pupillometer mode
(Sirius, Italy). CTs, scotopic, mesopic and photopic pupil diameter sizes were measured and
recorded at baseline, 1st and 3rd months.
Data obtained from cases were encoded and they were transferred to the computer program.
SPSS 20.0 software (SPSS Inc., Chicago, IL, USA) was used for statistical evaluation. Data
distribution was tested using Kolmogorov-Smirnov test. Baseline values and 1st, 3rd month
values were compared by using the repeated measure of ANOVA in intra-group evaluation and
independent samples t-test in inter-group evaluation, and the significance level of p-value
was accepted as 0,05 (P ≤ 0, 05). Progressions were evaluated by using repeated measures
analyses of variance-ANOVA (with the Bonferroni correction) and the correlation between
parameters were evaluated by using bivariate (Pearson's) correlation analysis. Positive
values and negative values were considered to be correlated in the same direction and
opposite direction, respectively in correlation analysis. Correlation coefficient values r ≥
|± 0.3| were accepted as correlation; and the significance level of P value that was below
0,05 was evaluated as the significant correlation.
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