Clinical trial NCT03144596: The Effects of α-adrenergic Receptor Antagonists on Choroid and Pupil
Official title: The Effects of Systemic Alfuzosin and Tamsulosin Hydrochloride on Choroidal Thickness and Pupil Diameter Sizes in Cases With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Pupil Anomaly
Choroid Disease
Lead sponsor: Kocatepe University
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 63
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, parallel-group clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Best corrected visual acuity (BCVA) ≥ 0.8
* Diagnosis of BPH and initiation of alfuzosin hydrochloride or tamsulosin hydrochloride treatments
* 45 years of age or older man

Exclusion Criteria:

* Occluded angle by gonioscopy (grade 0, narrow angle, grade I, grade II)
* Corneal scarring or cataract that prevents appearance of the fundus
* Formation of macular or peripheral retinal pathologies or choroidopathy
* Optic nerve pathologies such as optic neuropathy
* Spherical refractive error ≥ ±6.00 D or cylinder refractive error ≥ ±3.00 D
* Systemic diseases that may affect choroidal blood flow

Primary outcomes:
measure: Change from baseline choroidal thicknesses at 3 months
timeFrame: 1 month and 2 months
measure: Change from baseline pupil diameter sizes at 3 months
timeFrame: 1 month and 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Afyon Kocatepe University Eye Clinics
name: Mustafa Dogan, Asst. Prof.
role: STUDY_DIRECTOR
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