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

May 4, 2017 updated by: Kocatepe University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month and 2 months
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
1 month and 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocatepe University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2015

Primary Completion (Actual)

February 3, 2016

Study Completion (Actual)

November 19, 2016

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-2 2015/342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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