Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old (ATS6)
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Purpose
Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to <7 years old.
| Condition | Intervention | Phase |
|---|---|---|
|
Amblyopia |
Device: Eye Patch Procedure: Near activities Procedure: Distance activities |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old |
- Visual acuity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Visual acuity [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 425 |
| Study Start Date: | February 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Near activities
2 hours of daily patching combined with near visual activities while patching
|
Device: Eye Patch
2 hours daily patching
Other Name: Coverlet, 3M Opticlude, Ortopad®
Procedure: Near activities
near visual activities while patching
|
|
Active Comparator: Distance activities
2 hours of daily patching combined with distance visual activities while patching
|
Device: Eye Patch
2 hours daily patching
Other Name: Coverlet, 3M Opticlude, Ortopad®
Procedure: Distance activities
distance visual activities while patching
|
Detailed Description:
The value of "near visual activities" while patching for amblyopia is controversial. Some pediatric eye care providers currently recommend that the child perform near visual tasks while wearing a patch over the sound eye, while other pediatric eye care providers do not prescribe any specific visual tasks to be performed while the patch is worn.
In previous randomized studies of patching doses for amblyopia conducted by the Pediatric Eye Disease Investigator Group, near visual activities were incorporated into the prescribed treatment regimes. Although different doses of patching, combined with near visual activities, were successful in improving visual acuity in most children, it is unclear whether concurrent near visual activities enhanced the effect of patching.
This study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments.
The study has been designed as a simple trial that, other than the type of amblyopia therapy being determined through the randomization process, approximates standard clinical practice. The two treatment regimens for the 17 week treatment period are: 1) 2 hours of daily patching combined with near visual activities while patching and 2)2 hours of daily patching combined with distance visual activities while patching.
Eligibility| Ages Eligible for Study: | 3 Years to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients must be 3 to less than 7 years old with amblyopia due to strabismus, anisometropia, or both.
- Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference > 3 logMAR lines.
- Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.
Exclusion Criteria:
- Prior amblyopia treatment other than spectacles in the past month.
- More than one month of amblyopia treatment in the past 6 months.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00315198
| United States, Indiana | |
| Indiana University School of Optometry | |
| Bloomington, Indiana, United States, 47405 | |
| United States, Minnesota | |
| Mayo Clinic Department of Ophthalmology | |
| Rochester, Minnesota, United States, 55905 | |
| Study Chair: | Don Lyon, O.D. | Indiana University School of Optometry | |
| Study Chair: | Jonathan M. Holmes, M.D. | Mayo Clinic Department of Ophthalmology |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Roy W. Beck, M.D., Ph.D., Executive Director, Jaeb Center for Health Research |
| ClinicalTrials.gov Identifier: | NCT00315198 History of Changes |
| Other Study ID Numbers: | NEI-114, 2U10EY011751, 5-U10 EY 11751 |
| Study First Received: | April 14, 2006 |
| Last Updated: | March 23, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Jaeb Center for Health Research:
|
amblyopia patching visual activities |
Additional relevant MeSH terms:
|
Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases |
Neurologic Manifestations Sensation Disorders Signs and Symptoms Vision Disorders |
ClinicalTrials.gov processed this record on March 03, 2015