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Not yet recruitingNCT07743034Updated Aug 3, 2026

Iris Structural 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, Tamsulosin and Silodosin, 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

Inhibition of alpha-1 adrenergic receptors by drugs such as tamsulosin and silodosin, which are prescribed for the treatment of benign prostatic hyperplasia, can lead to intraoperative floppy iris syndrome (IFIS) during cataract surgery. IFIS is a phenomenon characterized by a small, poorly dilating pupil and causes surgical difficulty.

Main objective: To determine and compare changes in the anatomical structure of the iris in patients with BPH before and after treatment with tamsulosin and silodosin.

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. Imaging will be performed using an MS-39 device (manufactured by CSO, Italy); assessments will be conducted at two time points - before the start of treatment and after three months of continuous drug use. At baseline and three months after treatment, using AS-OCT, the DMR and SMR regions and other ocular angle indices will be measured. Medication adherence will be assessed by counting the capsules used by each patient.

Specific Objectives:

  1. To determine changes in the dilator muscle region (DMR) under scotopic, mesopic, photopic, and post-dilation conditions from baseline to the third month in the tamsulosin \& silodosin groups and compare them.
  2. To determine changes in SMR under scotopic, mesopic, photopic, and post-dilation conditions from baseline to the third month in the tamsulosin \& silodosin groups and compare them.
02

Conditions studied

  • Benign Prostatic Hyperplasia
  • Tamsulosin
  • Silodosin
  • Intraoperative Floppy Iris Syndrome
  • Tomography, Optical Coherence
  • Iris Diseases

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Keywords

  • Benign Prostatic Hyperplasia
  • Tamsulosin
  • Intraoperative Floppy Iris Syndrome
  • Tomography, Optical Coherence
  • Iris
  • Silodosin
  • IFIS
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 old with a definitive diagnosis of BPH by a urologist colleague.
  • Patients with moderate symptoms based on the International Prostate Symptom Score (IPSS): score 8 to 19
  • No prior use of alpha-blockers (tamsulosin, silodosin, doxazosin, etc.)
  • Satisfactory vision for imaging and acceptable scan quality according to device criteria.
  • Consent to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Insufficient image quality in assessments
  • History of intraocular surgery
  • Uncontrolled hypertension
  • Iris trauma
  • Patient unwillingness to continue participation in the study
  • Occurrence of unwanted systemic complications during the study
  • Incorrect 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. Changes in the dilator muscle region (DMR)

    To determine changes in the DMR under scotopic, mesopic, photopic, and post-dilation conditions.

    Time frame: From baseline to the third month.

  2. Changes in the sphincter muscle region (SMR)

    To determine changes in the SMR under scotopic, mesopic, photopic, and post-dilation conditions.

    Time frame: From baseline to the third month

  3. Changes in the DMR/SMR ratio

    To determine changes in the DMR/SMR ratio under scotopic, mesopic, photopic, and post-dilation conditions.

    Time frame: From baseline to the third month

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Apr 2027, 8 months later.

Of 28 phase 4 interventional studies under Prostatic Hyperplasia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 26. This study's planned 8 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2026
First posted
Aug 3, 2026
StartEst.
Aug 2026
Primary completionEst.
Apr 2027
CompletionEst.
Apr 2027
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
NCT07743034
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
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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