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.|
|ClinicalTrials.gov Identifier: NCT03402789|
Recruitment Status : Not yet recruiting
First Posted : January 18, 2018
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Amblyopia||Drug: Docosahexaenoic Acid Drug: Placebo Oral Tablet||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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 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.|
|Official Title:||Pilot Study to Evaluate Docosahexaenoic Acid as Treatment for Residual Amblyopia|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2020|
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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03402789
|Contact: Courtney Kraus, MDfirstname.lastname@example.org|
|Contact: Angeline M Nguyen, MDemail@example.com|
|United States, Maryland|
|Johns Hopkins Hospital, Wilmer Eye Institute||Not yet recruiting|
|Baltimore, Maryland, United States, 21287-9028|
|Contact: Courtney Kraus, MD 410-955-5492 firstname.lastname@example.org|
|Contact: Angeline M Nguyen, MD 972-767-9852|