Comparison of the Efficacy of Tamsulosin and Silodosin on Anatomical Iris Changes in Patients With Benign Prostatic Hyperplasia: A Single-blind Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Primary Endpoint
- Changes in the dilator muscle region (DMR)
Study Overview
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:
- 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.
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
- •Hypertension
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mohsen Pourazizi
Assistant Professor of Ophthalmology
Isfahan University of Medical Sciences