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

NCT07743034 | Not Yet Recruiting Phase 4

• 1 other identifier: IR.ARI.MUI.REC.1405.118
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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

Keywords

Benign Prostatic Hyperplasia; Tamsulosin; Intraoperative Floppy Iris Syndrome; Tomography, Optical Coherence; Iris; Silodosin; IFIS

Outcome Measures

Primary Outcomes (3)

• Changes in the dilator muscle region (DMR)

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

  From baseline to the third month.

• Changes in the sphincter muscle region (SMR)

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

  From baseline to the third month

• Changes in the DMR/SMR ratio

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

  From baseline to the third month

Study Arms (2)

Group 1: Tamsulosin

ACTIVE COMPARATOR

Tamsulosin 0.4 mg, daily.

Drug: tamsulosin 0.4mg

Group 2: Silodosin

ACTIVE COMPARATOR

Silodosin 8 mg, daily.

Drug: Silodosin 8 mg

Interventions

tamsulosin 0.4mg DRUG

Tamsulosin 0.4 mg, daily.

Group 1: Tamsulosin

Silodosin 8 mg DRUG

Silodosin 8 mg, daily.

Group 2: Silodosin

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohsen Pourazizi: lead

MeSH Terms

Conditions

Prostatic Hyperplasia; Iris Diseases

Interventions

Tamsulosin; silodosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Mohsen Pourazizi

  Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran

  STUDY DIRECTOR

Central Study Contacts

Mohsen Pourazizi, Assistant Professor

CONTACT

98 + 09379578055; m.pourazizi@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study is designed as assessor-blind, such that eligible patients presenting to the center will be evaluated by the treating physician and will receive drug A or B. The person responsible for assessing the outcomes will not be informed of the group assignment or the final result.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07