Docosahexaenoic Acid (DHA) Supplementation in Amblyopia

Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Amblyopia

In brief

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 along with eye patching, while one third of participants will receive a placebo along with eye patching.

Key facts

Study ID

NCT03402789

Run by

Johns Hopkins University

People needed

0

Starts

2024-01-01

Expected to finish

2024-12-30

Last updated by the study team

2024-02-09

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital, Wilmer Eye Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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