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

Phase 4Not Yet RecruitingNCT07743034

Mohsen Pourazizi40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Benign Prostatic Hyperplasia

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Changes in the DMR/SMR ratio

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