Pupil Size and Choroidal Thickness Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients

Sponsor
Mohsen Pourazizi
Study ID
NCT07743060
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tamsulosin 0.4mg — DRUG
    Tamsulosin 0.4 mg, daily
  • Silodosin 8 mg — DRUG
    Silodosin 8 mg, daily.

Study Details

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.

Key Dates

First listed
Aug 3, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1: Tamsulosin
    Tamsulosin 0.4 mg, daily.
  • Active Comparator: Group 2: Silodosin
    Silodosin 8 mg, daily.

Primary Outcome Measure

Mean change in pupil diameter [ Time Frame: From baseline to the third month. ]

Central Contacts

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