Comparison of Tamsulosin and Silodosin on Pupil Size and Choroidal Thickness in Patients With Benign Prostatic Hyperplasia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Mean change in pupil diameter
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Hypertension
结局指标
主要结局
Mean change in pupil diameter
时间窗: From baseline to the third month.
Mean change in pupil diameter under scotopic, mesopic, and photopic lighting conditions.
Mean change in choroidal thickness
时间窗: From baseline to the third month.
次要结局
未报告次要终点
研究者
Mohsen Pourazizi
Assistant Professor of Ophthalmology
Isfahan University of Medical Sciences