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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Mohsen Pourazizi, Assistant Professor
- Telefonnummer: 98 + 09379578055
- E-post: m.pourazizi@yahoo.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group 1: Tamsulosin
Tamsulosin 0.4 mg, daily.
|
Tamsulosin 0.4 mg, daily.
|
|
Aktiv komparator: Group 2: Silodosin
Silodosin 8 mg, daily.
|
Silodosin 8 mg, daily.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in the dilator muscle region (DMR)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Mohsen Pourazizi, Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Genitala sjukdomar, manliga
- Prostatasjukdomar
- Manliga urogenitala sjukdomar
- Ögonsjukdomar
- Uveal sjukdomar
- Prostatahyperplasi
- Irissjukdomar
- Svavelföreningar
- Organiska kemikalier
- Kolväten
- Kolväten, cykliska
- Kolväten, aromatisk
- Amider
- Bensiverivat
- Bensensulfonamider
- Sulfonamider
- Sulfoner
- Tamsulosin
- silodosin
Andra studie-ID-nummer
- IR.ARI.MUI.REC.1405.118
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