The Effects of α-adrenergic Receptor Antagonists on Choroid and Pupil
NCT ID: NCT03144596
Last Updated: 2017-05-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
63 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-10-29
Study Completion Date
2016-11-19
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Benign Prostatic Hyperplasia
Pupil Anomaly
Choroid Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
prospective, randomized, parallel-group clinical trial
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Alfuzosin Hydrochloride
Alfuzosin hydrochloride 10 mg tablet by mouth, every 24 hours for 3 months
Group Type
EXPERIMENTAL
Alfuzosin Hydrochloride 10 MG
Intervention Type
DRUG
Alfuzosin hydrochloride Tablet
Tamsulosin Hydrochloride
Tamsulosin hydrochloride 0.4 mg tablet by mouth, every 24 hours for 3 months
Group Type
ACTIVE_COMPARATOR
Tamsulosin Hydrochloride 0.4 MG
Intervention Type
DRUG
Tamsulosin Hydrochloride Tablet
Interventions
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Alfuzosin Hydrochloride 10 MG
Alfuzosin hydrochloride Tablet
Intervention Type
DRUG
Tamsulosin Hydrochloride 0.4 MG
Tamsulosin Hydrochloride Tablet
Intervention Type
DRUG
Other Intervention Names
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Xatral
Flomax
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
45 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Kocatepe University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Mustafa Dogan, Asst. Prof.
Role: STUDY_DIRECTOR
Afyon Kocatepe University Eye Clinics
References
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Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984 Sep;132(3):474-9. doi: 10.1016/s0022-5347(17)49698-4.
Reference Type
BACKGROUND
Yuan J, Liu Y, Yang Z, Qin X, Yang K, Mao C. The efficacy and safety of alpha-1 blockers for benign prostatic hyperplasia: an overview of 15 systematic reviews. Curr Med Res Opin. 2013 Mar;29(3):279-87. doi: 10.1185/03007995.2013.766594. Epub 2013 Jan 29.
Reference Type
BACKGROUND
McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.
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BACKGROUND
Filson CP, Hollingsworth JM, Clemens JQ, Wei JT. The efficacy and safety of combined therapy with alpha-blockers and anticholinergics for men with benign prostatic hyperplasia: a meta-analysis. J Urol. 2013 Dec;190(6):2153-60. doi: 10.1016/j.juro.2013.05.058. Epub 2013 May 30.
Reference Type
BACKGROUND
Osman NI, Chapple CR, Cruz F, Desgrandchamps F, Llorente C, Montorsi F. Silodosin : a new subtype selective alpha-1 antagonist for the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia. Expert Opin Pharmacother. 2012 Oct;13(14):2085-96. doi: 10.1517/14656566.2012.714368. Epub 2012 Aug 28.
Reference Type
BACKGROUND
Oelke M, Gericke A, Michel MC. Cardiovascular and ocular safety of alpha1-adrenoceptor antagonists in the treatment of male lower urinary tract symptoms. Expert Opin Drug Saf. 2014 Sep;13(9):1187-97. doi: 10.1517/14740338.2014.936376. Epub 2014 Jul 29.
Reference Type
BACKGROUND
Hollingsworth JM, Wilt TJ. Lower urinary tract symptoms in men. BMJ. 2014 Aug 14;349:g4474. doi: 10.1136/bmj.g4474.
Reference Type
BACKGROUND
Schwinn DA, Michelotti GA. alpha1-adrenergic receptors in the lower urinary tract and vascular bed: potential role for the alpha1d subtype in filling symptoms and effects of ageing on vascular expression. BJU Int. 2000 Apr;85 Suppl 2:6-11. doi: 10.1046/j.1464-410x.2000.00061.x. No abstract available.
Reference Type
BACKGROUND
Hatano A, Takahashi H, Tamaki M, Komeyama T, Koizumi T, Takeda M. Pharmacological evidence of distinct alpha 1-adrenoceptor subtypes mediating the contraction of human prostatic urethra and peripheral artery. Br J Pharmacol. 1994 Nov;113(3):723-8. doi: 10.1111/j.1476-5381.1994.tb17053.x.
Reference Type
BACKGROUND
de Mey C. alpha(1)-blockers for BPH: are there differences? Eur Urol. 1999;36 Suppl 3:52-63. doi: 10.1159/000052349.
Reference Type
BACKGROUND
Dunn CJ, Matheson A, Faulds DM. Tamsulosin: a review of its pharmacology and therapeutic efficacy in the management of lower urinary tract symptoms. Drugs Aging. 2002;19(2):135-61. doi: 10.2165/00002512-200219020-00004.
Reference Type
BACKGROUND
Bird ST, Delaney JA, Brophy JM, Etminan M, Skeldon SC, Hartzema AG. Tamsulosin treatment for benign prostatic hyperplasia and risk of severe hypotension in men aged 40-85 years in the United States: risk window analyses using between and within patient methodology. BMJ. 2013 Nov 5;347:f6320. doi: 10.1136/bmj.f6320.
Reference Type
BACKGROUND
Chrischilles E, Rubenstein L, Chao J, Kreder KJ, Gilden D, Shah H. Initiation of nonselective alpha1-antagonist therapy and occurrence of hypotension-related adverse events among men with benign prostatic hyperplasia: a retrospective cohort study. Clin Ther. 2001 May;23(5):727-43. doi: 10.1016/s0149-2918(01)80022-9.
Reference Type
BACKGROUND
Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin. J Cataract Refract Surg. 2005 Apr;31(4):664-73. doi: 10.1016/j.jcrs.2005.02.027.
Reference Type
BACKGROUND
Abdel-Aziz S, Mamalis N. Intraoperative floppy iris syndrome. Curr Opin Ophthalmol. 2009 Jan;20(1):37-41. doi: 10.1097/ICU.0b013e32831bc0ad.
Reference Type
BACKGROUND
Mamalis N. Intraoperative floppy-iris syndrome associated with systemic alpha blockers. J Cataract Refract Surg. 2008 Jul;34(7):1051-2. doi: 10.1016/j.jcrs.2008.05.017. No abstract available.
Reference Type
BACKGROUND
Chang DF, Braga-Mele R, Mamalis N, Masket S, Miller KM, Nichamin LD, Packard RB, Packer M; ASCRS Cataract Clinical Committee. ASCRS White Paper: clinical review of intraoperative floppy-iris syndrome. J Cataract Refract Surg. 2008 Dec;34(12):2153-62. doi: 10.1016/j.jcrs.2008.08.031.
Reference Type
BACKGROUND
Nickla DL, Wallman J. The multifunctional choroid. Prog Retin Eye Res. 2010 Mar;29(2):144-68. doi: 10.1016/j.preteyeres.2009.12.002. Epub 2009 Dec 29.
Reference Type
BACKGROUND
Konno F, Takayanagi I. Characterization of postsynaptic alpha 1-adrenoceptors in the rabbit iris dilator smooth muscle. Naunyn Schmiedebergs Arch Pharmacol. 1986 Jul;333(3):271-6. doi: 10.1007/BF00512940.
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BACKGROUND
Shapiro BL, Petrovic V, Lee SE, Flach A, McCaffery S, O'Brien JM. Choroidal detachment following the use of tamsulosin (Flomax). Am J Ophthalmol. 2007 Feb;143(2):351-3. doi: 10.1016/j.ajo.2006.09.032. Epub 2006 Oct 23.
Reference Type
BACKGROUND
Kerimoglu H, Zengin N, Ozturk B, Gunduz K. Unilateral chemosis, acute onset myopia and choroidal detachment following the use of tamsulosin. Acta Ophthalmol. 2010 Mar;88(2):e20-1. doi: 10.1111/j.1755-3768.2008.01503.x. Epub 2009 Mar 19. No abstract available.
Reference Type
BACKGROUND
Nieminen T, Ylitalo R, Koobi T, Ylitalo P, Kahonen M. The vasodilatory effect of alfuzosin and tamsulosin in passive orthostasis: a randomised, double-blind, placebo-controlled study. Eur Urol. 2005 Mar;47(3):340-5. doi: 10.1016/j.eururo.2004.11.002. Epub 2004 Dec 29.
Reference Type
BACKGROUND
Gu N, Kim J, Lim KS, Shin KH, Kim TE, Lee B, Shin SG, Jang IJ, Yu KS. Assessment of the effect of mirodenafil on the hemodynamics of healthy male Korean volunteers administered tamsulosin: a randomized, double-blind, placebo-controlled, 2-period crossover study. Clin Ther. 2012 Sep;34(9):1929-39. doi: 10.1016/j.clinthera.2012.08.002. Epub 2012 Aug 24.
Reference Type
BACKGROUND
Kiel JW, Lovell MO. Adrenergic modulation of choroidal blood flow in the rabbit. Invest Ophthalmol Vis Sci. 1996 Mar;37(4):673-9.
Reference Type
BACKGROUND
Tanabe H, Ito Y, Iguchi Y, Ozawa S, Ishikawa K, Terasaki H. Correlation between cross-sectional shape of choroidal veins and choroidal thickness. Jpn J Ophthalmol. 2011 Nov;55(6):614-9. doi: 10.1007/s10384-011-0079-2. Epub 2011 Aug 27.
Reference Type
BACKGROUND
Vance SK, Imamura Y, Freund KB. The effects of sildenafil citrate on choroidal thickness as determined by enhanced depth imaging optical coherence tomography. Retina. 2011 Feb;31(2):332-5. doi: 10.1097/IAE.0b013e3181eef0ae.
Reference Type
BACKGROUND
Other Identifiers
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2011-KAEK-2 2015/342
Identifier Type: -
Identifier Source: org_study_id
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