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Not yet recruitingNCT07743060Updated Aug 3, 2026

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

A Phase 4 interventional study of tamsulosin 0.4mg and Silodosin 8 mg in Benign Prostatic Hyperplasia, Silodosin and Tamsulosin, sponsored by Mohsen Pourazizi. Not yet recruiting. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Mohsen Pourazizi · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Benign Prostatic Hyperplasia
  • Silodosin
  • Tamsulosin
  • Choroid
  • Iris Disease
  • Tomography, Optical Coherence

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Keywords

  • Benign Prostatic Hyperplasia
  • Silodosin
  • Tamsulosin
  • Choroid/anatomy & histology
  • Iris/anatomy & histology
  • Tomography, Optical Coherence
03

In context

Prostatic Hyperplasia

827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.

This study's planned enrollment of 40 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

Mohsen Pourazizi is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Group 1: Tamsulosin

    Tamsulosin 0.4 mg, daily.

    Drug: tamsulosin 0.4mg

  • Active comparator
    Group 2: Silodosin

    Silodosin 8 mg, daily.

    Drug: Silodosin 8 mg

Interventions

06

What researchers measure

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.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07743060
Lead sponsor
Mohsen Pourazizi
Responsible party
Mohsen Pourazizi (Assistant Professor of Ophthalmology, Isfahan University of Medical Sciences) — Sponsor-investigator
First posted
Aug 3, 2026
Start date
Aug 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Aug 3, 2026

Study contacts

Mohsen Pourazizi, Assistant Professor
Contact
m.pourazizi@yahoo.com
98 + 09379578055
Mohsen Pourazizi, Assistant Professor
study director · Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Tamsulosin · Silodosin

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