Docosahexaenoic Acid (DHA) Supplementation in Amblyopia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of Omega-DEK in Childhood Apraxia of Speech

NCT07216001

Childhood Apraxia of Speech Verbal Apraxia Autism

NOT_YET_RECRUITING PHASE2

Docosahexaenoic Acid on Breath Holding Spells in Children

NCT03965988

Breath Holding Attack

RECRUITING PHASE3

Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery

NCT01901588

Strabismus Delirium on Emergence Pediatric Disorders

COMPLETED PHASE4

A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine

NCT06422377

Dravet Syndrome (DS) Lennox-Gastaut Syndrome (LGS)

TERMINATED PHASE3

Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia

NCT00004493

Lactic Acidosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amblyopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Docosahexaenoic Acid

Intervention Type DRUG

Docosahexaenoic acid 1,200mg daily plus 2 hours of eye patching daily

Placebo arm

Participants will receive a placebo pill daily in addition to 2 hours of daily eye patching of the affected eye.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo tablet daily plus 2 hours of eye patching daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Docosahexaenoic Acid

Docosahexaenoic acid 1,200mg daily plus 2 hours of eye patching daily

Intervention Type DRUG

Placebo Oral Tablet

Placebo tablet daily plus 2 hours of eye patching daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DHA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes