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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00525174 |
This study is a randomized clinical trial designed to evaluate 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 visual acuity below amblyopic eye visual acuity predicts improvement in acuity, and (4) to determine whether changing 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.
Condition | Intervention | Phase |
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Amblyopia |
Device: Bangerter filters Device: Patching Procedure: Near activities |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Trial of Full-Time Bangerter Filters Versus Part-Time Daily Patching for the Treatment of Moderate Amblyopia in Children |
Estimated Enrollment: | 170 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Patching: Active Comparator
2 hours daily patching of the sound eye plus one hour near activities while patching
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Device: Patching
2 hours daily patching of the sound eye
Procedure: Near activities
one hour near visual activities
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Bangerter filters: Active Comparator
Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
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Device: Bangerter filters
Bangerter filter worn on sound eye spectacle lens full time
Procedure: Near activities
one hour near visual activities
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Amblyopia is the most common cause of monocular visual impairment in children, estimated to affect as many as 3.6% of the childhood population. The natural history of amblyopia is relatively unknown although it has been reported that visual acuity may deteriorate further without treatment.
Although occlusion or patching of the sound eye has been the mainstay for amblyopia therapy, alternative treatment such as pharmacological or optical penalization may be as effective. In a randomized, controlled clinical trial of 419 children, 3 years to less than 7 years old with moderate amblyopia, patching was compared to atropine. Although improvement with atropine was initially slower, both treatments produced similar improvement after 6 months.
Although both patching and atropine have been proven effective for treating amblyopia, neither treatment is without adverse side effects. Patching is associated with compliance difficulties, the need for continuous monitoring, and social stigma. Negative side effects observed in children treated with atropine include light sensitivity, facial flushing, and fever. In a randomized clinical trial comparing patching to atropine as a treatment for amblyopia, a questionnaire to assess the impact of patching and atropine treatment on the child and family indicated that both treatments were well tolerated overall, however, patching had lower compliance and higher social stigma than atropine.
Bangerter filters, also known as Bangerter foils, have been used mainly as secondary amblyopia therapy following patching or atropine to either further improve or maintain the visual gain. One advantage of Bangerter filters compared to patching is that the lower density filters are not readily apparent and therefore would be expected to increase patient compliance due to reduced social stigma. Another advantage of Bangerter filters is that there is no opportunity for skin irritation from bandage adhesive, a commonly-reported side effect of patching. In addition, there is a theoretical advantage that Bangerter filters are less disruptive to binocular function during treatment compared to other modalities such as patching.
Few data are available comparing Bangerter filters with patching for the treatment of amblyopia. Bonsall randomized 14 patients, 3 to 10 years old, with previously untreated strabismic/anisometropic amblyopia to either 6 hours of daily patching or full-time Bangerter filters. Baseline amblyopic eye acuity was 20/30 to 20/400 for the patching group and 20/30 to 20/200 for the Bangerter group. The Bangerter filter prescribed was the minimum density foil needed to elicit a switch in fixation from the sound eye to the amblyopic eye. Visual acuity was measured every 6-8 weeks until the amblyopic eye visual acuity was equal to that of the sound eye, an improvement that was achieved in 5 of the 14 at the time the study was stopped. The average time to achieve equal vision between the amblyopic and sound eyes was about 4.5 months (142 days) for the foil group versus about 9 months (272 days) for the patching group. Both forms of therapy were equally tolerated. Despite good preliminary data, a large randomized clinical trial comparing the effectiveness of Bangerter filters to patching for the treatment of amblyopia has yet to be conducted.
Ages Eligible for Study: | 3 Years to 9 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
No amblyopia treatment other than spectacles in last 6 months
*Any treatment more than 6 months prior to enrollment is acceptable
Exclusion Criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 |
Study Chair: | Robert P. Rutstein, O.D., M.S. | University of Alabama at Birmingham |
Study Chair: | Graham E. Quinn, M.D., MSCE | Children's Hospital of Philadelphia |
Responsible Party: | Jaeb Center for Health Research ( Roy W. Beck, M.D., Ph.D. ) |
Study ID Numbers: | NEI-136 |
Study First Received: | August 31, 2007 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00525174 |
Health Authority: | United States: Federal Government |
Amblyopia Patching Bangerter filters |
Signs and Symptoms Sensation Disorders Vision Disorders Amblyopia |
Eye Diseases Neurologic Manifestations Central Nervous System Diseases Brain Diseases |
Nervous System Diseases |