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

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Eye Diseases Genital Diseases Genital Diseases, Male Intraoperative Floppy Iris Syndrome Iris Diseases Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Silodosin Tamsulosin Tomography, Optical Coherence Urogenital Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

tamsulosin 0.4mg

Drug

Tamsulosin 0.4 mg, daily.

Silodosin 8 mg

Drug

Silodosin 8 mg, daily.

Primary outcomes

Changes in the dilator muscle region (DMR)

Time frame: From baseline to the third month.

To determine changes in the DMR under scotopic, mesopic, photopic, and post-dilation conditions.
Changes in the sphincter muscle region (SMR)

Time frame: From baseline to the third month

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

Time frame: From baseline to the third month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohsen Pourazizi, Assistant Professor

CONTACT

[email protected]

98 + 09379578055

Sponsors and collaborators

Lead sponsor

Mohsen Pourazizi

Other

Registry information

Official study title

Comparison of the Efficacy of Tamsulosin and Silodosin on Anatomical Iris Changes in Patients With Benign Prostatic Hyperplasia: A Single-blind Randomized Clinical Trial

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 3, 2026
Registry last updated: Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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