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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age50+
SponsorMohsen Pourazizi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • tamsulosin 0.4mg

    Drug

    Tamsulosin 0.4 mg, daily

  • Silodosin 8 mg

    Drug

    Silodosin 8 mg, daily.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group 1: TamsulosinActive comparator 1 intervention
Group B: Group 2: SilodosinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean change in pupil diameter

Mean change in pupil diameter under scotopic, mesopic, and photopic lighting conditions.

Time frame
From baseline to the third month.
2

Mean change in choroidal thickness

Time frame
From baseline to the third month.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohsen Pourazizi

Lead sponsor

Isfahan University of Medical Sciences

Sponsor institution

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