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DHA Supplementation for Lazy Eye

Q: What research has been conducted previously pertaining to the therapeutic benefits of Docosahexaenoic Acid?

At present, 4 clinical studies are underway to investigate the efficacy of Docosahexaenoic Acid. Out of these trials, one is in phase 3 and has locations across Baltimore, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>.

Q: Who is eligible for inclusion in this research project?

This clinical trial is seeking 30 minors aged 3-17 who are suffering from lazy eye. To meet the inclusion criteria, candidates must have a visual acuity in their amblyopic eye between 20/50 and 20/400, with no more than 4 letters or one logMAR line of improvement within two consecutive visits at least four weeks apart. Furthermore, they need to be under 6 months old spectacle correction (if applicable), had an ocular examination within six months prior to enrollment and possess a parent available for follow up over a half year period that can be contacted by phone regularly. It should also be noted that the investigator must assess if

Q: What conditions are often treated using Docosahexaenoic Acid?

Docosahexaenoic Acid is typically used to address dietary insufficiency, yet can also be utilized in the treatment of hyperlipidemia and inadequate triglyceride control when administered with statins. Additionally, it has applications as a nutritional supplement.

Q: Is there availability for enrolment in this clinical trial?

Currently, this research is not recruiting volunteers. It was published on January 1st 2023 and has been updated most recently as of 24th January 2022. In the meantime, there are twenty trials actively looking for participants to assist with lazy eye studies, while four additional investigations need help in researching Docosahexaenoic Acid (DHA).

Q: Are senior citizens permitted to participate in this investigation?

The parameters of this medical trial require prospective participants to be aged 3-17. Additionally, there are 20 clinical trials for minors and 3 specifically designed for those over 65 years old.

Q: What is the current enrollment capacity for this clinical research project?

This trial is not presently seeking participants. First listed on January 1st 2023 and updated lastly on the 24th of January 2022, no more recruitment is anticipated at this time. If you are curious about other studies, currently there are 20 active clinical trials recruiting patients with amblyopia and 4 medical experiments searching for individuals to join their research into Docosahexaenoic Acid.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.

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

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

Anemia

Gastrointestinal disorders - Other: Burping

Headache

Fall

Back pain

Dyspepsia - Heart Burn

Bruising

Gastroesophageal reflux disease

Allergic rhinitis

Breast pain

Diarrhea

Flu like symptoms

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 / 4Eligibility criteria met

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

2,260 Previous Clinical Trials

14,820,780 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What research has been conducted previously pertaining to the therapeutic benefits of Docosahexaenoic Acid?

"At present, 4 clinical studies are underway to investigate the efficacy of Docosahexaenoic Acid. Out of these trials, one is in phase 3 and has locations across Baltimore, Maryland."

Answered by AI

Who is eligible for inclusion in this research project?

"This clinical trial is seeking 30 minors aged 3-17 who are suffering from lazy eye. To meet the inclusion criteria, candidates must have a visual acuity in their amblyopic eye between 20/50 and 20/400, with no more than 4 letters or one logMAR line of improvement within two consecutive visits at least four weeks apart. Furthermore, they need to be under 6 months old spectacle correction (if applicable), had an ocular examination within six months prior to enrollment and possess a parent available for follow up over a half year period that can be contacted by phone regularly. It should also be noted that the investigator must assess if"

Answered by AI

What conditions are often treated using Docosahexaenoic Acid?

"Docosahexaenoic Acid is typically used to address dietary insufficiency, yet can also be utilized in the treatment of hyperlipidemia and inadequate triglyceride control when administered with statins. Additionally, it has applications as a nutritional supplement."

Answered by AI

Is there availability for enrolment in this clinical trial?

"Currently, this research is not recruiting volunteers. It was published on January 1st 2023 and has been updated most recently as of 24th January 2022. In the meantime, there are twenty trials actively looking for participants to assist with lazy eye studies, while four additional investigations need help in researching Docosahexaenoic Acid (DHA)."

Answered by AI

Are senior citizens permitted to participate in this investigation?

"The parameters of this medical trial require prospective participants to be aged 3-17. Additionally, there are 20 clinical trials for minors and 3 specifically designed for those over 65 years old."

Answered by AI

What is the current enrollment capacity for this clinical research project?

"This trial is not presently seeking participants. First listed on January 1st 2023 and updated lastly on the 24th of January 2022, no more recruitment is anticipated at this time. If you are curious about other studies, currently there are 20 active clinical trials recruiting patients with amblyopia and 4 medical experiments searching for individuals to join their research into Docosahexaenoic Acid."

Answered by AI