Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315198
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
2006-04-14
Brief Title:
Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to 7 Years Old
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to 7 Years Old
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATS6
Brief Summary:
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
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 22 hours of daily patching combined with distance visual activities while patching
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 22 hours of daily patching combined with distance visual activities while patching
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U10EY011751 | NIH | None | httpsreporternihgovquickSearch5U10EY011751 |
| 2U10EY011751 | NIH | None | None |