Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00525174 · ClinicalTrials.gov registry record · Phase 3
Full-time Bangerter Filters Versus Part-time Daily Patching for Moderate Amblyopia in Children
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 186
- Enrollment target
NCT00525174 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 186 participants.
The verdict
NCT00525174, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 186 participants
- Enrollment target
Study Summary
This study is a randomized clinical trial designed to evaluate the non-inferiority of Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate amblyopia (20/40 to 20/80) in children ages 3 to \< 10 years. Secondary objectives of this study are (1) to determine the time course of visual improvement with Bangerter filter treatment, (2) to compare patient quality of life, measured by a modified Amblyopia Treatment Index, between patients treated with patching vs. Bangerter filters, (3) to determine whether blurring the sound eye to a visual acuity worse than the amblyopic eye predicts improvement in acuity, and (4) to determine whether a change in fixation to the amblyopic eye is predictive of improvement in visual acuity. The primary outcome assessment is visual acuity at 24 weeks for both the amblyopic and sound eyes. The primary analytic approach for the amblyopic eye acuity will involve construction of a one-sided 95% confidence interval to assess non-inferiority based on a treatment group comparison of logMAR visual acuity scores adjusted for baseline visual acuity scores in an analysis of covariance (ANCOVA) model. Sound eye acuity data will be reported for each treatment regimen at the 24-week visit as mean change (logMAR lines) from baseline and as the distribution of the number of lines of change from baseline.
Interventions
- DEVICE Patching
- PROCEDURE Near activities
- DEVICE Bangerter filters
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2007-11 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00525174
The ClinicalTrials.gov registry entry for NCT00525174 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Patching is the first listed.
NCT00525174 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00525174 about?
NCT00525174 is a clinical study titled "Full-time Bangerter Filters Versus Part-time Daily Patching for Moderate Amblyopia in Children". This study is a randomized clinical trial designed to evaluate the non-inferiority of Bangerter filters compared to 2 hours of daily patching as a primary treatment for moderate amblyopia (20/40 to 20/80) in children ages 3 to \< 10 years. Secondary objectives of this study are (1) to determine the...
What is the current status of trial NCT00525174?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 186 participants. The study started on 2007-11. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00525174?
The interventions under investigation include: Patching (DEVICE), Near activities (PROCEDURE), Bangerter filters (DEVICE).
Who is sponsoring clinical trial NCT00525174?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.