Pilot Study to Evaluate Docosahexaenoic Acid as Treatment for Residual Amblyopia
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Visual acuity response with DHA
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Docosahexaenoic Acid (Drug)
Placebo arm
Participants will receive a placebo pill daily in addition to 2 hours of daily eye patching of the affected eye.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Visual acuity response with DHA
时间窗: 6 months
Measurement of the visual acuity change in those in the DHA arm compared to the placebo arm
次要结局
未报告次要终点