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Docosahexaenoic Acid (DHA) Supplementation in Amblyopia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03402789
Recruitment Status : Not yet recruiting
First Posted : January 18, 2018
Last Update Posted : August 27, 2020
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study evaluates the addition of docosahexaenoic acid (DHA) to eye patching in the treatment of residual amblyopia in children ages 3 to 18 years old. Two thirds of participants will receive DHA along with eye patching, while one third of participants will receive a placebo along with eye patching.

Condition or disease Intervention/treatment Phase
Amblyopia Drug: Docosahexaenoic Acid Drug: Placebo Oral Tablet Phase 1 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single blinded randomized controlled pilot study with 2/3 of participants randomized into the treatment arm and 1/3 of participants randomized into the placebo arm.
Masking: Single (Participant)
Masking Description: The participants will not be informed of whether they are taking the treatment drug or the placebo. Technicians measuring participants' visual outcomes are also masked. The principal investigator and co-investigators will know how the patient's are randomized.
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Docosahexaenoic Acid as Treatment for Residual Amblyopia
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Experimental: Docosahexaenoic acid (DHA) arm
Participants will receive a pill of docosahexaenoic acid 1,200mg daily in addition to 2 hours of daily eye patching of the affected eye.
Drug: Docosahexaenoic Acid
Docosahexaenoic acid 1,200mg daily plus 2 hours of eye patching daily
Other Name: DHA

Placebo Comparator: Placebo arm
Participants will receive a placebo pill daily in addition to 2 hours of daily eye patching of the affected eye.
Drug: Placebo Oral Tablet
Placebo tablet daily plus 2 hours of eye patching daily

Primary Outcome Measures :
  1. Visual acuity response with DHA [ Time Frame: 6 months ]
    Measurement of the visual acuity change in those in the DHA arm compared to the placebo arm

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03402789

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Contact: Courtney Kraus, MD 410-955-5492
Contact: Angeline M Nguyen, MD 972-767-9852

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United States, Maryland
Johns Hopkins Hospital, Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028
Contact: Courtney Kraus, MD    410-955-5492   
Contact: Angeline M Nguyen, MD    972-767-9852      
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Courtney Kraus, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University Identifier: NCT03402789    
Other Study ID Numbers: IRB00150865
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Docosahexaenoic acid
Long chain fatty acid
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases