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The Effects of α-adrenergic Receptor Antagonists on Choroid and Pupil

Sponsor
Kocatepe University (Other)
Overall Status
Completed
CT.gov ID
NCT03144596
Collaborator
(none)
63
Enrollment
2
Arms
12.7
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Alfuzosin Hydrochloride 10 MG
  • Drug: Tamsulosin Hydrochloride 0.4 MG
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective, randomized, parallel-group clinical trialprospective, randomized, parallel-group clinical trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Systemic Alfuzosin and Tamsulosin Hydrochloride on Choroidal Thickness and Pupil Diameter Sizes in Cases With Benign Prostatic Hyperplasia
Actual Study Start Date :
Oct 29, 2015
Actual Primary Completion Date :
Feb 3, 2016
Actual Study Completion Date :
Nov 19, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alfuzosin Hydrochloride

Alfuzosin hydrochloride 10 mg tablet by mouth, every 24 hours for 3 months

Drug: Alfuzosin Hydrochloride 10 MG
Alfuzosin hydrochloride Tablet
Other Names:
  • Xatral

    		•
    Active Comparator: Tamsulosin Hydrochloride

    Tamsulosin hydrochloride 0.4 mg tablet by mouth, every 24 hours for 3 months

    Drug: Tamsulosin Hydrochloride 0.4 MG
    Tamsulosin Hydrochloride Tablet
    Other Names:
  • Flomax

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline choroidal thicknesses at 3 months [1 month and 2 months]

      Choroidal thicknesses (CTs) measurement under the fovea, 3 mm nasal to the fovea and 3 mm temporal to the fovea at baseline, 1st and 3rd month, and recording as submacular (SCT), nasal (NCT) and temporal (TCT) choroidal thicknesses.

    2. Change from baseline pupil diameter sizes at 3 months [1 month and 2 months]

      Mesopic, scotopic and photopic pupil diameter sizes measurement at baseline, 1st and 3rd months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kocatepe University

    Investigators

    • Study Director: Mustafa Dogan, Asst. Prof., Afyon Kocatepe University Eye Clinics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kocatepe University
    ClinicalTrials.gov Identifier:
    NCT03144596
    Other Study ID Numbers:
    • 2011-KAEK-2 2015/342
    First Posted:
    May 9, 2017
    Last Update Posted:
    May 9, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Choroid Diseases
    Prostatic Hyperplasia
    Hyperplasia
    Tamsulosin
    Alfuzosin

    Study Results

    No Results Posted as of May 9, 2017