Menu
Not yet recruiting NCT07743060

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

Phase IV Interventional Benign Prostatic Hyperplasia Silodosin Tamsulosin Choroid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tamsulosin 0.4mg, Silodosin 8 mg.
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia, Silodosin, Tamsulosin, Choroid. Basic parameters: from 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Tamsulosin and Silodosin on Pupil Size and Choroidal Thickness in Patients With Benign Prostatic Hyperplasia

Overview

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

  • Drug tamsulosin 0.4mg
    Tamsulosin 0.4 mg, daily
  • Drug Silodosin 8 mg
    Silodosin 8 mg, daily.

Primary outcome measures

  • Mean change in pupil diameter [Time frame: From baseline to the third month.]
  • Mean change in choroidal thickness [Time frame: From baseline to the third month.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07743060 · IR.MUI.MED.REC.1404.400

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗