Status:
COMPLETED
Increasing Patching for Amblyopia in Children 3 to < 8 Years Old
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Amblyopia
Eligibility:
All Genders
3-7 years
Phase:
PHASE3
Brief Summary
This study is designed to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is stil...
Detailed Description
Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of ...
Eligibility Criteria
Inclusion
- Major Eligibility Criteria for Run-in Phase
- Age 3 to \< 8 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity in the amblyopic eye between 20/50 and 20/400 inclusive
- Visual acuity in the sound eye 20/32 or better and inter-eye acuity difference \>3 logMAR lines
- Amblyopia treatment within the past 6 months subject to the following stipulations:
- No more than 6 weeks of any amblyopia treatment other than spectacles (except for patients being treated with 2 hours of patching per day who are entering the study on treatment)
- No simultaneous treatment with patching and atropine
- No use of atropine in combination with the sound eye spectacle lens reduced by more than 1.50 D
- Maximum level of treatment within the past 6 months:
- Patching: up to 2 hours daily
- Atropine: up to once daily
- Wearing spectacles with optimal correction (if applicable); if amblyopic eye acuity is 20/80 or better, then VA must be stable in glasses. If amblyopic eye acuity is 20/100 or worse, then spectacles and patching can be initiated simultaneously.
- Eligibility Criteria for Randomization:
- Amblyopic eye acuity of 20/40 to 20/160 with an inter-ocular difference of \>2 lines, or amblyopic eye acuity of 20/32 with 3 lines of IOD.
- Reasonable compliance with prescribed treatment, defined as wearing the patch at least 10 hours per week.
Exclusion
- Currently using vision therapy or orthoptics
- Ocular cause for reduced visual acuity (nystagmus per se does not exclude the patient if the above visual acuity criteria are met)
- Prior intraocular or refractive surgery
- Known skin reaction to patch or bandage adhesives
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT00945100
Start Date
August 1 2009
End Date
March 1 2013
Last Update
July 13 2016
Active Locations (2)
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1
Southern California College of Optometry
Fullerton, California, United States, 92831
2
Duke University Eye Center
Durham, North Carolina, United States, 27710