Status:
WITHDRAWN
Docosahexaenoic Acid (DHA) Supplementation in Amblyopia
Lead Sponsor:
Johns Hopkins University
Conditions:
Amblyopia
Eligibility:
All Genders
3-17 years
Phase:
PHASE1
PHASE2
Brief Summary
This study evaluates the addition of docosahexaenoic acid (DHA) to eye patching in the treatment of residual amblyopia in children ages 3 to 18 years old. Two thirds of participants will receive DHA a...
Detailed Description
Amblyopia is the most common cause of monocular visual impairment in children and adults. There are well established therapies for this condition, which typically involve eye patching or atropine eye ...
Eligibility Criteria
Inclusion
- Age 3 to \< 18 years
- Amblyopia associated with strabismus, anisometropia, or both
- Visual acuity, measured in each eye (without cycloplegia) within 7 days prior to enrollment using letter matching or the ETDRS protocol as follows:
- Visual acuity in the amblyopic eye of 20/50 to 20/400
- Visual acuity in the sound eye of 20/25 or better
- No improvement or decline in best-corrected amblyopic eye visual acuity between two consecutive visits at least 4 weeks apart using the same testing method and optimal spectacle correction (if needed), with no improvement of more than 4 letters or one logMAR line.
- Previous or current treatment of amblyopia with either patching or atropine drops
- Spectacle correction (if applicable) for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction that is no more than 6 months old
- Ocular examination within 6 months prior to enrollment
- Parent available for at least 6 months of follow-up, has home phone (or access to phone), and willing to be contacted by clinical site staff
- In the investigator's judgment, the subject is likely to comply with prescribed treatment (e.g., no history of poor compliance with patching treatment).
Exclusion
- Myopia more than -8.00 D (spherical equivalent) in either eye.
- Current vision therapy or orthoptics
- Ocular cause for reduced visual acuity
- Prior intraocular or refractive surgery
- Strabismus surgery planned within 6 months
- Known immunodeficiency or hypercoagulable state
- Known skin reactions to patch or bandage adhesives
- Current treatment with topical atropine
- Constant deviations larger than 35 prism diopters
- Patients whose guardians have significant language or hearing impairment that would inhibit them from understanding the consent form or the procedures of the study will be excluded
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03402789
Start Date
January 1 2024
End Date
December 30 2024
Last Update
February 9 2024
Active Locations (1)
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1
Johns Hopkins Hospital, Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028