← Back to Search

DHA Supplementation for Lazy Eye

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 will test whether adding DHA to eye patching can improve vision in kids with residual amblyopia. 2/3 of participants will get DHA, while 1/3 will get a placebo.

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.Check my eligibility
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.See study design
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
Select...
I am between 3 and 17 years old.
Select...
I have lazy eye due to crossed eyes, different eye prescriptions, or both.
Select...
I have been treated for lazy eye with patching or eye drops.
Select...
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:
Select...
I am currently undergoing vision therapy.
Select...
I have an eye condition that affects my vision.
Select...
I have had eye surgery before.
Select...
I am currently using atropine eye drops.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual acuity response with DHA

Side effects data

From 2020 Phase 2 trial • 65 Patients • NCT01849250
6%
Anemia
6%
Gastrointestinal disorders - Other: Burping
6%
Headache
3%
Breast pain
3%
Diarrhea
3%
Gastroesophageal reflux disease
3%
Back pain
3%
Allergic rhinitis
3%
Dyspepsia - Heart Burn
3%
Bruising
3%
Fall
3%
Flu like symptoms
3%
Myalgia
3%
Flatulence
3%
Localized edema
3%
Pain
3%
Respiratory, thoracic and mediastinal disorders - Other, Chest Congestion
3%
Sinusitis
3%
Skin infection
3%
Sore throat
3%
Urticaria
3%
Vertigo
100%
80%
60%
40%
20%
0%
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

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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,285 Previous Clinical Trials
14,843,065 Total Patients Enrolled
Courtney Kraus, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Docosahexaenoic Acid Clinical Trial Eligibility Overview. Trial Name: NCT03402789 — Phase 1 & 2
Lazy Eye Research Study Groups: Docosahexaenoic acid (DHA) arm, Placebo arm
Lazy Eye Clinical Trial 2023: Docosahexaenoic Acid Highlights & Side Effects. Trial Name: NCT03402789 — Phase 1 & 2
Docosahexaenoic Acid 2023 Treatment Timeline for Medical Study. Trial Name: NCT03402789 — Phase 1 & 2
~0 spots leftby Jul 2025