What side effects are associated with this type of intervention?

Common treatments for Lazy Eye (Amblyopia) include eye patching, atropine eye drops, and vision therapy. Eye patching can cause skin irritation and discomfort. Atropine eye drops may lead to light sensitivity, eye irritation, and blurred vision. Vision therapy, which involves exercises to improve eye coordination, generally has minimal side effects but can sometimes cause eye strain or headaches. DHA supplementation, which supports neural development and function, is generally well-tolerated but may cause mild gastrointestinal symptoms such as nausea or diarrhea.

What prior FDA approvals exist?

Currently, the primary FDA-approved treatments for Lazy Eye (Amblyopia) include eye patching and atropine eye drops, which are used to force the use of the weaker eye and improve its function. There are no specific FDA approvals for treatments involving Docosahexaenoic Acid (DHA) for Lazy Eye. However, DHA is being studied for its potential benefits in neural development and function, which could support its use in combination with traditional treatments like eye patching.

What other types of research exist?

Promising novel alternatives to DHA for treating lazy eye (amblyopia) include: 1) Trigeminal Nerve Stimulation (TNS), which has shown potential in improving attention and cognitive function in children with ADHD and may have applications in amblyopia treatment. 2) Digital therapeutics, which are emerging as effective adjuncts to traditional treatments and could be adapted for amblyopia. 3) Omega-3/6 fatty acids, which have been studied for ADHD and other neurodevelopmental disorders and may offer benefits similar to DHA. Patients should discuss these options with their healthcare provider to determine the best course of action.

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DHA Supplementation for Lazy Eye

Q: What is the mechanism of action of this treatment?

The most common treatments for Lazy Eye (Amblyopia) include eye patching, atropine eye drops, and vision therapy. These treatments work by enhancing neural development and function in the weaker eye. Eye patching covers the stronger eye, forcing the weaker eye to work harder and strengthen its neural connections. Atropine eye drops blur the vision in the stronger eye, similarly encouraging the weaker eye to develop better neural pathways. Vision therapy involves exercises that improve eye coordination and focus, enhancing neural plasticity and visual processing. These treatments are crucial for Lazy Eye patients as they help develop and strengthen the brain's neural pathways responsible for vision, improving visual acuity and preventing long-term vision problems.

Phase 1 & 2

Waitlist Available

Led By Courtney Kraus, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 3 to < 18 years

Amblyopia associated with strabismus, anisometropia, or both

Must not have

Current vision therapy or orthoptics

Ocular cause for reduced visual acuity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Summary

This trial tests if adding DHA, a nutrient that helps brain and eye development, to eye patching can improve vision in children with residual amblyopia. These children still have vision problems despite standard treatments. DHA might help their brains and eyes work better together, potentially offering a safe and affordable way to enhance current treatments.

Who is the study for?

Children aged 3 to under 18 with lazy eye (amblyopia) due to misalignment or different vision between eyes, who have stable but poor vision in the affected eye despite previous treatments like patching. They must not be highly nearsighted, undergoing certain other eye treatments, planning strabismus surgery soon, or have conditions that affect understanding of the study.

What is being tested?

The trial is testing if taking docosahexaenoic acid (DHA) supplements can improve outcomes for children with amblyopia when used alongside traditional eye patching therapy. Two-thirds of participants will receive DHA and one-third a placebo, both groups continuing with eye patching.

What are the potential side effects?

While specific side effects are not listed here, DHA is generally considered safe but could potentially cause mild digestive discomfort or allergic reactions in some individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 17 years old.

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I have lazy eye due to crossed eyes, different eye prescriptions, or both.

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I have been treated for lazy eye with patching or eye drops.

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My parent is available for follow-ups, has a phone, and agrees to be contacted.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing vision therapy.

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I have an eye condition that affects my vision.

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I have had eye surgery before.

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I am currently using atropine eye drops.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Visual acuity response with DHA

Side effects data

From 2020 Phase 2 trial • 65 Patients • NCT01849250

Anemia

Gastrointestinal disorders - Other: Burping

Headache

Allergic rhinitis

Back pain

Breast pain

Bruising

Diarrhea

Dyspepsia - Heart Burn

Fall

Flu like symptoms

Gastroesophageal reflux disease

Myalgia

Flatulence

Localized edema

Pain

Respiratory, thoracic and mediastinal disorders - Other, Chest Congestion

Sinusitis

Skin infection

Sore throat

Urticaria

Vertigo

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Docosahexaenoic Acid

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Docosahexaenoic acid (DHA) armExperimental Treatment1 Intervention

Participants will receive a pill of docosahexaenoic acid 1,200mg daily in addition to 2 hours of daily eye patching of the affected eye.

Group II: Placebo armPlacebo Group1 Intervention

Participants will receive a placebo pill daily in addition to 2 hours of daily eye patching of the affected eye.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docosahexaenoic Acid

2007

Completed Phase 2

~200

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lazy Eye (Amblyopia) include eye patching, atropine eye drops, and vision therapy. These treatments work by enhancing neural development and function in the weaker eye. Eye patching covers the stronger eye, forcing the weaker eye to work harder and strengthen its neural connections. Atropine eye drops blur the vision in the stronger eye, similarly encouraging the weaker eye to develop better neural pathways. Vision therapy involves exercises that improve eye coordination and focus, enhancing neural plasticity and visual processing. These treatments are crucial for Lazy Eye patients as they help develop and strengthen the brain's neural pathways responsible for vision, improving visual acuity and preventing long-term vision problems.