Docosahexaenoic Acid (DHA) Supplementation in Amblyopia

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 drops. Despite these therapies, a substantial proportion of treated patients
have some degree of residual amblyopia, even when treatment takes place early during the
critical period visual development.

Investigators have tried to augment standard amblyopia treatment with medications that appear
to promote visual cortex plasticity, thus addressing the neuronal pathogenesis of amblyopia.
For example, levodopa, was described as a possible drug to treat amblyopia due to its ability
to enhance cortical plasticity. While the rationale behind such treatments is promising,
results from well-powered clinical trials have not shown a statistically significant effect
of these treatments.

Docosahexaenoic acid (DHA) is a long chain polyunsaturated fatty acid (LCPUFA) that is
considered essential for the maturation of the developing brain and retina. DHA, which is
commercially available a nutritional supplement, has been added to infant formula, with
studies showing that it improves visual development in premature infants. Randomized studies
have shown that DHA supplementation of infant formula results in higher visual acuity in
infants. Our proposal is aimed at conducting a prospective randomized pilot study to provide
a preliminary assessment of the efficacy and safety of DHA combined with daily ocular
occlusion therapy in children and teenagers with residual amblyopia. To our knowledge, this
would be the first study aiming to treat amblyopia with DHA. If found to be effective, DHA
may be considered a safe and inexpensive adjunct to our conventional means of treating
amblyopia.

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