Recovery From Amblyopia With Cholinesterase Inhibitors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Amblyopia Eye Visual Acuity Improvement
研究概览
简要总结
Amblyopia is the leading cause of monocular visual impairment in children and adults. Despite conventional treatment with patching or eye drops, many older children and adults do not achieve normal vision in the amblyopic eye.
Donepezil is an acetylcholinesterase inhibitor that increases levels of the neurotransmitter acetylcholine in the brain. Use of acetylcholinesterase inhibitors has been demonstrated by the Hensch lab (Department of Neurology, FM Kirby Neurobiology Center) at Boston Children's Hospital to improve vision and reverse amblyopia in animal models.
The purpose of this study is to evaluate the efficacy of oral donepezil as treatment for residual amblyopia (20/50 - 20/400) in patients 8 years of age and older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥8 years
- •Amblyopia associated with strabismus and/or anisometropia
- •Amblyopic eye visual acuity of 20/50 - 20/400
- •Sound eye visual acuity of ≥20/25
- •For 8 to 17 year olds, current amblyopia treatment of at least 2 hours of daily patching for at least 4 weeks during the pre-enrollment period with no improvement in best-corrected amblyopic eye visual acuity (<5 letters or 1 logMAR line between 2 consecutive visual acuity measurements at least 4 weeks apart while on current treatment)
- •For ≥18 year olds, history of prior amblyopia treatment with patching
- •Wearing optimal optical correction with stable amblyopic eye visual acuity (<5 letters or 1 logMAR line of improvement during 2 consecutive visual acuity measurements at least 4 weeks apart)
- •Complete eye examination within 6 months prior to enrollment
- •Available for at least 6 months of follow-up, have access to a phone, and willing to be contacted by clinical staff
- •Likely to comply with prescribed treatment and unlikely, if applicable, to continue to improve with 2 hours of daily patching alone
排除标准
- •Myopia more than -6.00 D spherical equivalent
- •Presence of associated findings that could cause reduced visual acuity
- •Previous intraocular or refractive surgery
- •Strabismus surgery planned within 22 weeks
- •Current vision therapy or orthoptics
- •Treatment with topical atropine within the past 4 weeks
- •Presence of cardiac condition, asthma, obstructive pulmonary disease, seizure disorder, urinary incontinence, and/or peptic ulcer disease receiving concurrent NSAIDs
- •History of gastrointestinal bleeding from peptic ulcer disease
- •Known psychological problems
- •Known skin reaction to patch or bandage adhesives for 8 to 17 year olds
- •Known allergies or contraindications to the use of acetylcholinesterase inhibitors
- •Prior acetylcholinesterase inhibitor treatment
- •Current use of medication for the treatment of ADHD or psychological disorders
- •Inability to swallow pills equivalent in size to the 5 mg donepezil tablet
- •Females who are pregnant, lactating, or intending to become pregnant within the next 6 months
研究组 & 干预措施
Donepezil
干预措施: Donepezil (Drug)
Donepezil
干预措施: Patching (Other)
结局指标
主要结局
Amblyopia Eye Visual Acuity Improvement
时间窗: 22 weeks after enrollment
Study treatment will last for 12 weeks. Primary outcome measure is analysis of the proportion of subjects with improvement in amblyopic eye visual acuity of ≥ 15 letters or 3 logMAR lines at 22 weeks after 10 weeks off study treatment.
次要结局
- Amblyopic Eye Visual Acuity(4, 8, 12, and 22 weeks after enrollment)
- Recurrence of Amblyopia after 10 Weeks Off Study Treatment(22 weeks after enrollment)
- Adverse Events(4, 8, 12, and 22 weeks after enrollment)
- Adverse Events Requiring Discontinuation of Study Treatment(4, 8, and 12 weeks after enrollment)
- Completion of Study Treatment(12 weeks after enrollment)
- Sound Eye Visual Acuity(22 weeks after enrollment)
研究者
Carolyn Wu
Assistant Professor of Ophthalmology
Boston Children's Hospital