Pupil Size and Choroidal Thickness Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hype… (NCT07743060) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Pupil Size and Choroidal Thickness Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients
40 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.