Docosahexaenoic Acid (DHA) Supplementation in Amblyopia

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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