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

NCT07743060 | Not Yet Recruiting Phase 4

• 1 other identifier: IR.MUI.MED.REC.1404.400
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Mean change in pupil diameter

  Mean change in pupil diameter under scotopic, mesopic, and photopic lighting conditions.

  From baseline to the third month.

• Mean change in choroidal thickness

  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 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

You may not qualify if:

• 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

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, Assistant Professor

  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