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

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ClinicalTrials.gov Identifier: NCT03144596
Recruitment Status : Completed
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Kocatepe University

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
Benign Prostatic Hyperplasia Pupil Anomaly Choroid Disease 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, 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 : October 29, 2015
Actual Primary Completion Date : February 3, 2016
Actual Study Completion Date : November 19, 2016


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 Name: 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 Name: Flomax




Primary Outcome Measures :
  1. Change from baseline choroidal thicknesses at 3 months [ Time Frame: 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 [ Time Frame: 1 month and 2 months ]
    Mesopic, scotopic and photopic pupil diameter sizes measurement at baseline, 1st and 3rd months



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144596


Sponsors and Collaborators
Kocatepe University
Investigators
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Study Director: Mustafa Dogan, Asst. Prof. Afyon Kocatepe University Eye Clinics

Publications:

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Responsible Party: Kocatepe University
ClinicalTrials.gov Identifier: NCT03144596     History of Changes
Other Study ID Numbers: 2011-KAEK-2 2015/342
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Choroid Diseases
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Uveal Diseases
Eye Diseases
Tamsulosin
Alfuzosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents