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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: Completed Phase 3 study, sponsored by Jaeb Center for Health Research.
NCT00525174 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 186 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Visual acuity was measured in each eye using the Amblyopia Treatment Study (ATS) visual acuity testing protocol resulting in a Snellen acuity score that can range from 20/16 to 20/800 for ages 3 to \<7; or with the electronic early treatment diabetic retinopathy study (E-ETDRS) method for 7 to \<10 year olds which resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Scores were converted to log of minimum angle of resolution (logMAR) equ
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 |
What the finished NCT00525174 record still lists
NCT00525174 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 3 interventions - of which Patching is the first listed.
NCT00525174 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT00525174's enrollment target sits among peer trials
186 1412th of 2000 higher than 584 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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