Benign Prostatic Hyperplasia, Intraoperative Floppy Iris Syndrome, Iris Diseases, Silodosin, Tamsulosin, Tomography, Optical Coherence
Conditions
Keywords
Benign Prostatic Hyperplasia, Tamsulosin, Intraoperative Floppy Iris Syndrome, Tomography, Optical Coherence, Iris, Silodosin, IFIS
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: 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.
Interventions
DRUGtamsulosin 0.4mg
Tamsulosin 0.4 mg, daily.
DRUGSilodosin 8 mg
Silodosin 8 mg, daily.
Sponsors
Mohsen Pourazizi
Study design
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
Sex/Gender
MALE
Age
50 Years to No maximum
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 * Diabetes * Hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the dilator muscle region (DMR) | 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) | 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 | From baseline to the third month | To determine changes in the DMR/SMR ratio under scotopic, mesopic, photopic, and post-dilation conditions. |
Contacts
CONTACTMohsen Pourazizi, Assistant Professor
STUDY_DIRECTORMohsen Pourazizi
Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
Outcome results
None listed