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.
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
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
Mohsen Pourazizi
Lead sponsor
Isfahan University of Medical Sciences
Sponsor institution