Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old (ATS6)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00315198 |
|
Recruitment Status
:
Completed
First Posted
: April 18, 2006
Last Update Posted
: March 24, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Amblyopia | Device: Eye Patch Procedure: Near activities Procedure: Distance activities | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 425 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | February 2005 |
| Actual Primary Completion Date : | December 2007 |
| Actual Study Completion Date : | December 2007 |
| Arm | Intervention/treatment |
|---|---|
|
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
|
- Visual acuity [ Time Frame: 8 weeks ]
- Visual acuity [ Time Frame: 17 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 3 Years to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
Publications of Results:
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 ( U.S. NIH Grant/Contract ) 5U10EY011751 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 18, 2006 Key Record Dates |
| Last Update Posted: | March 24, 2010 |
| Last Verified: | May 2009 |
Keywords provided by Jaeb Center for Health Research:
|
amblyopia patching visual activities |
Additional relevant MeSH terms:
|
Amblyopia Brain Diseases Central Nervous System Diseases Nervous System Diseases Vision Disorders |
Sensation Disorders Neurologic Manifestations Eye Diseases Signs and Symptoms |