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Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients

NCT07743034 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-03

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

tamsulosin 0.4mg

Tamsulosin 0.4 mg, daily.

DRUG

Silodosin 8 mg

Silodosin 8 mg, daily.

Sponsors & Collaborators

  • Mohsen Pourazizi

    lead OTHER

Principal Investigators

  • Mohsen Pourazizi · Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-04-30
Completion
2027-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07743034 on ClinicalTrials.gov