Benign Prostatic Hyperplasia, Choroid, Iris Disease, Silodosin, Tamsulosin, Tomography, Optical Coherence
Conditions
Keywords
Benign Prostatic Hyperplasia, Silodosin, Tamsulosin, Choroid/anatomy & histology, Iris/anatomy & histology, Tomography, Optical Coherence
Brief summary
Benign prostatic hyperplasia (BPH) is a common disease in men and is treated with alpha-blockers, particularly tamsulosin and silodosin. Studies suggest that these drugs may affect α1a receptors in the iris dilator muscle, causing structural changes in the iris and pupillary disturbances, and increasing the risk of intraoperative floppy iris syndrome (IFIS) during cataract surgery. Main objective: To compare the effect of tamsulosin and silodosin on pupil size and choroidal thickness in patients with BPH. Men aged 50 years and older with a definitive diagnosis of BPH who have no prior history of alpha-blocker use will be enrolled in one of the two treatment arms - tamsulosin or silodosin. Assessments will be conducted at two time points - before the start of treatment and after three months of continuous. * Pupillography will be performed at three standard illumination levels - scotopic 0.04 lux, mesopic 4 lux, and photopic 50 lux - with pupil diameter automatically recorded under each condition using the MS-39 device (manufactured by CSO, Italy). * Choroidal assessment will use EDI-OCT (Heidelberg) macular imaging, measuring choroidal thickness at the subfoveal position and at 500 and 1000 micron nasal and temporal points. To reduce daily fluctuations related to circadian rhythm, all imaging will be performed within a fixed window of 9-11 a.m. by a single trained operator. drug use.
Interventions
DRUGtamsulosin 0.4mg
Tamsulosin 0.4 mg, daily
DRUGSilodosin 8 mg
Silodosin 8 mg, daily.
Sponsors
Mohsen Pourazizi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study is designed as assessor-blind, such that eligible patients presenting to the center will be evaluated by the treating physician and will receive drug A or B. The person responsible for assessing the outcomes will not be informed of the group assignment or the final result.
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men ≥ 50 years of age with a definitive diagnosis of BPH by a collaborating urologist. * Patients with moderate symptoms based onthe International Prostate Symptom Score (IPSS): score 8 to 19 * No prior use of any alpha-blocker (tamsulosin, silodosin, doxazosin, etc.) * Vision adequate for imaging * Consent to participate in the study * No history of any intraocular surgery; no active or structural ocular disease affecting the pupil/iris, such as glaucoma, uveitis, pseudoexfoliation syndrome, pigment dispersion syndrome. * No use of pupil-affecting eye drops within the past 2 weeks
Exclusion criteria
* High myopia (SE ≤ -6.00 D) or axial length \> 26.5 mm, in order to control for its effect on choroidal thickness * History of trauma or injury to the iris * Insufficient image quality during assessments * Patient unwilling to continue participation in the study * Occurrence of unwanted systemic adverse effects during the study * Improper medication adherence during the study * Diabetes * Hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in pupil diameter | From baseline to the third month. | Mean change in pupil diameter under scotopic, mesopic, and photopic lighting conditions. |
| Mean change in choroidal thickness | From baseline to the third month. | — |
Contacts
CONTACTMohsen Pourazizi, Assistant Professor
STUDY_DIRECTORMohsen Pourazizi, Assistant Professor
Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
Outcome results
None listed