deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT03144596

The Effects of α-adrenergic Receptor Antagonists on Choroid and Pupil

The Effects of Systemic Alfuzosin and Tamsulosin Hydrochloride on Choroidal Thickness and Pupil Diameter Sizes in Cases With Benign Prostatic Hyperplasia

Sponsor: Kocatepe University

Updated 6 times since 2017 Last updated: May 4, 2017 Started: Oct 29, 2015 Primary completion: Feb 3, 2016 Completion: Nov 19, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03144596, this PHASE4 trial focuses on Benign Prostatic Hyperplasia and Choroid Disease and remains completed. Sponsored by Kocatepe University, it has been updated 6 times since 2015, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

The local authorized clinical trials ethics committee approved the study and this study was performed following the principles of the Declaration of Helsinki. Detailed information was given to patients about clinical applications and tests, and signed informed consent forms were also obtained from all patients. 32 right eyes of 32 men with diagnosis of BPH initiated on AH (Xatral®) (10 mg/day) and 31 right eyes of 31 men with diagnosis of BPH initiated on TH (Flomax®) (0.4 mg/day) were included in this self-controlled prospective clinical trial. Urologists in the urology clinic made diagnosis of BPH, and 63 men diagnosis of BPH were directed towards eye clinic. AH or TH treatments were randomly recommended for previously untreated patients with newly diagnosis of BPH by urologists. After providing information to patients about the disease and treatment, patients predicted to show adherence to treatment, were enrolled in the study. Ophthalmological examinations were performed in all cases. Choroidal thicknesses (CTs) were measured under the fovea, 3 mm nasal to the fovea and 3 mm temporal to the fovea, and they were recorded as submacular (SCT), nasal (NCT) and temporal (TCT) choroidal thicknesses. CTs were measured and recorded by using EDI-OCT imaging (Cirrus HD 4000,...

The local authorized clinical trials ethics committee approved the study and this study was performed following the principles of the Declaration of Helsinki. Detailed information was given to patients about clinical applications and tests, and signed informed consent forms were also obtained from all patients. 32 right eyes of 32 men with diagnosis of BPH initiated on AH (Xatral®) (10 mg/day) and 31 right eyes of 31 men with diagnosis of BPH initiated on TH (Flomax®) (0.4 mg/day) were included in this self-controlled prospective clinical trial. Urologists in the urology clinic made diagnosis of BPH, and 63 men diagnosis of BPH were directed towards eye clinic. AH or TH treatments were randomly recommended for previously untreated patients with newly diagnosis of BPH by urologists. After providing information to patients about the disease and treatment, patients predicted to show adherence to treatment, were enrolled in the study.

Ophthalmological examinations were performed in all cases. Choroidal thicknesses (CTs) were measured under the fovea, 3 mm nasal to the fovea and 3 mm temporal to the fovea, and they were recorded as submacular (SCT), nasal (NCT) and temporal (TCT) choroidal thicknesses. CTs were measured and recorded by using EDI-OCT imaging (Cirrus HD 4000, Carl Zeis Meditec, CA, USA). Mesopic, scotopic and photopic pupil diameter sizes were measured and recorded by using Scheimpflug/Placido photography-based topography system in the pupillometer mode (Sirius, Italy). CTs, scotopic, mesopic and photopic pupil diameter sizes were measured and recorded at baseline, 1st and 3rd months.

Data obtained from cases were encoded and they were transferred to the computer program. SPSS 20.0 software (SPSS Inc., Chicago, IL, USA) was used for statistical evaluation. Data distribution was tested using Kolmogorov-Smirnov test. Baseline values and 1st, 3rd month values were compared by using the repeated measure of ANOVA in intra-group evaluation and independent samples t-test in inter-group evaluation, and the significance level of p-value was accepted as 0,05 (P ≤ 0, 05). Progressions were evaluated by using repeated measures analyses of variance-ANOVA (with the Bonferroni correction) and the correlation between parameters were evaluated by using bivariate (Pearson's) correlation analysis. Positive values and negative values were considered to be correlated in the same direction and opposite direction, respectively in correlation analysis. Correlation coefficient values r ≥ \|± 0.3\| were accepted as correlation; and the significance level of P value that was below 0,05 was evaluated as the significant correlation.

Status Flow

~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Present [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

Show 1 earlier version
  1. Jul 2017 — Jun 2018 [monthly]

    Completed PHASE4

    First recorded

Oct 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Kocatepe University
Data source: Kocatepe University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.