Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00094744
Status:
COMPLETED
Last Update Posted:
2010-09-09
First Post:
2004-10-22
Brief Title:
Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
A Randomized Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia
Status:
COMPLETED
Status Verified Date:
2010-09
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:
None
Brief Summary:
The goals of this study are
To determine whether the visual acuity improvement obtained with part-time 6 hours patching is equivalent to the visual acuity improvement obtained with full-time patching all or all but one waking hour for severe amblyopia
To develop more precise estimates than currently available for the visual acuity improvement that occurs during treatment of amblyopia with patching
To identify factors that may be associated with successful treatment of amblyopia with patching
To determine whether the visual acuity improvement obtained with part-time 6 hours patching is equivalent to the visual acuity improvement obtained with full-time patching all or all but one waking hour for severe amblyopia
To develop more precise estimates than currently available for the visual acuity improvement that occurs during treatment of amblyopia with patching
To identify factors that may be associated with successful treatment of amblyopia with patching
Detailed Description:
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults Patching has been the mainstay of amblyopia therapy It is generally held that the response to treatment is best when it is instituted at an early age particularly by age two or three and is poor when attempted after eight years of age
For severe amblyopia it is generally accepted that occlusion with patching is the standard of care Other modalities of treatment such as atropine penalization and optical penalization are widely considered insufficient as initial treatments for severe amblyopia However controversy exists with regard to how many hours per day of patching should be prescribed Advocates of full-time patching purport that such a regimen is needed to restore visual acuity more rapidly and more effectively Advocates of part-time patching believe it to be better tolerated by the child and family therefore producing less stress on the parent-child relationship and producing better results through better compliance Part-time patching may also promote the development of binocularity in patients who have straight-eyes reduce the chance of a straight-eyed patient developing manifest strabismus or losing stereopsis and reduce the incidence of reverse- or occlusion-amblyopia
The study is a randomized trial comparing daily patching regimes for children with severe amblyopia It will consist of about 160 children Patients in the severe 20100 to 20400 group will patch part-time 6 hours or full-time all or all but one waking hour of each day for the 4 month study period There are at least two follow up visits during the 4-month period Visual acuity is the major study outcome It is assessed at the 4-month exam
For severe amblyopia it is generally accepted that occlusion with patching is the standard of care Other modalities of treatment such as atropine penalization and optical penalization are widely considered insufficient as initial treatments for severe amblyopia However controversy exists with regard to how many hours per day of patching should be prescribed Advocates of full-time patching purport that such a regimen is needed to restore visual acuity more rapidly and more effectively Advocates of part-time patching believe it to be better tolerated by the child and family therefore producing less stress on the parent-child relationship and producing better results through better compliance Part-time patching may also promote the development of binocularity in patients who have straight-eyes reduce the chance of a straight-eyed patient developing manifest strabismus or losing stereopsis and reduce the incidence of reverse- or occlusion-amblyopia
The study is a randomized trial comparing daily patching regimes for children with severe amblyopia It will consist of about 160 children Patients in the severe 20100 to 20400 group will patch part-time 6 hours or full-time all or all but one waking hour of each day for the 4 month study period There are at least two follow up visits during the 4-month period Visual acuity is the major study outcome It is assessed at the 4-month exam
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 |
|---|---|---|---|
| 2U10EY011751 | NIH | None | httpsreporternihgovquickSearch2U10EY011751 |