Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients
Comparison of the Efficacy of Tamsulosin and Silodosin on Anatomical Iris Changes in Patients With Benign Prostatic Hyperplasia: A Single-blind Randomized Clinical Trial
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.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Mohsen Pourazizi, Assistant Professor
- 电话号码:98 + 09379578055
- 邮箱:m.pourazizi@yahoo.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Group 1: Tamsulosin
Tamsulosin 0.4 mg, daily.
|
Tamsulosin 0.4 mg, daily.
|
|
有源比较器:Group 2: Silodosin
Silodosin 8 mg, daily.
|
Silodosin 8 mg, daily.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in the dilator muscle region (DMR)
大体时间:From baseline to the third month.
|
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)
大体时间:From baseline to the third month
|
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
大体时间:From baseline to the third month
|
To determine changes in the DMR/SMR ratio under scotopic, mesopic, photopic, and post-dilation conditions.
|
From baseline to the third month
|
合作者和调查者
调查人员
- 研究主任:Mohsen Pourazizi、Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IR.ARI.MUI.REC.1405.118
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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