Phase 3
N=186
Full-time Bangerter Filters Versus Part-time Daily Patching for Moderate Amblyopia in Children
Amblyopia
Bottom Line
View on ClinicalTrials.gov: NCT00525174 ↗Enrolled (actual)
186
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks — 1; 0; 3; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bangerter filters (Device); Patching (Device); Near activities (Procedure)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks |
1; 0; 3; 0; 3; 1 | — |
| PRIMARY Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks |
0.25; 0.23 | — |
| PRIMARY Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks |
1; 0; 2; 0; 5; 1 | 0.02 sig |
| PRIMARY Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks |
1.9; 2.3 | 0.09 |
| SECONDARY Mean Interocular Difference at 24 Weeks |
2.3; 2.3 | — |
| SECONDARY Distribution of Subjects With Interocular Difference <1 logMAR Line at 24 Weeks |
15; 10 | 0.27 |
| SECONDARY Distribution of Subjects With >= 20/25 Amblyopic Eye Visual Acuity at 24 Weeks |
29; 27 | 0.86 |
| SECONDARY Distribution of Subjects With 3 or More Lines of Improvement |
31; 31 | 0.61 |
| SECONDARY Distribution of Patient Characteristics at the 24-week Outcome Exam. |
34; 43; 47; 45; 63; 61 | — |
| SECONDARY Mean and SD of Change in Visual Acuity in the Amblyopic Eye From Baseline to 24-Week Outcome Examination According to Patient Characteristics |
2.1; 2.4; 1.7; 2.2; 1.8; 2.3 | — |
| SECONDARY Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-Week Outcome by Treatment Group: All Subjects |
12; 15; 61; 58; 3; 7 | 0.90 |
| SECONDARY Distribution of Change in Randot Preschool Stereoacuity From Baseline to 24-week Outcome by Treatment Group: Subjects With Anisometropia and No Strabismus |
7; 9; 25; 21; 1; 4 | 0.88 |
| SECONDARY Distribution of Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks |
0; 0; 1; 5; 17; 8 | — |
| SECONDARY Mean Change in Fellow Eye Visual Acuity From Baseline to 24 Weeks |
0.09; 0.36 | 0.07 |
| SECONDARY Impact of Treatment on Patient and Family at 6 Weeks |
2.1; 2.3 | 0.03 sig |
| SECONDARY Impact of Treatment on Patient and Family at 24 Weeks |
1.9; 2.3 | <0.001 sig |
| SECONDARY Adverse Effects of Treatment on Patient and Family at 6 Weeks |
2.2; 2.2 | 0.90 |
| SECONDARY Adverse Effects of Treatment on Patient and Family at 24 Weeks |
1.9; 2.2 | 0.01 sig |
| SECONDARY Compliance With Treatment at 6 Weeks |
2.3; 2.5 | 0.12 |
| SECONDARY Compliance With Treatment at 24 Weeks |
2.1; 2.6 | 0.001 sig |
| SECONDARY Social Stigma From Treatment at 6 Weeks |
1.7; 2.4 | <0.001 sig |
| SECONDARY Social Stigma From Treatment at 24 Weeks |
1.6; 2.4 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Age 3 to = 69 letters) in sound eye
- Interocular difference >= 3 logMAR lines (>= 15 letters)
- No amblyopia treatment other than spectacles in last 6 months
*Any treatment more than 6 months prior to enrollment is acceptable
- Currently wearing spectacles
- Appropriate spectacles have been worn for 16 weeks prior to enrollment or visual acuity documented to be stable
- No myopia > -6.00 D spherical equivalent in either eye
- Cycloplegic refraction within 6 months prior to enrollment
- Ocular examination within 6 months prior to enrollment
Exclusion Criteria
- Current vision therapy or orthoptics
- Ocular cause for reduced visual acuity
- Prior intraocular or refractive surgery
- Known skin reactions to patch or bandage adhesives
Data sourced from ClinicalTrials.gov (NCT00525174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.