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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
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 belowSelect...
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:Select...
I am currently undergoing vision therapy.
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I have an eye condition that affects my vision.
Select...
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
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 • NCT018492506%
Anemia
6%
Gastrointestinal disorders - Other: Burping
6%
Headache
3%
Allergic rhinitis
3%
Back pain
3%
Breast pain
3%
Bruising
3%
Diarrhea
3%
Dyspepsia - Heart Burn
3%
Fall
3%
Flu like symptoms
3%
Gastroesophageal reflux disease
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.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,631 Total Patients Enrolled
Courtney Kraus, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently undergoing vision therapy.I have an eye condition that affects my vision.Your eyes have a constant deviation of more than 35 prism diopters.My vision in my weaker eye hasn't gotten better or worse over 4 weeks.I have been treated for lazy eye with patching or eye drops.Your nearsightedness is worse than -8.00 diopters in either eye.I am currently using atropine eye drops.You have had skin reactions to patches or bandages before.I have had eye surgery before.I am between 3 and 17 years old.I am scheduled for eye muscle surgery within the next 6 months.You have a weakened immune system or a condition that causes blood to clot too easily.Your weak eye can see at a level between 20/50 and 20/400.I have lazy eye due to crossed eyes, different eye prescriptions, or both.My glasses prescription is based on a recent eye exam.Your vision in your non-affected eye is 20/25 or better.My parent is available for follow-ups, has a phone, and agrees to be contacted.
Research Study Groups:
This trial has the following groups:- Group 1: Docosahexaenoic acid (DHA) arm
- Group 2: Placebo arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.