Phase 2a randomised controlled feasibility trial of a new 'balanced binocular viewing' treatment for unilateral amblyopia in children age 3-8 years: trial protocol.
Phase 2a randomised controlled feasibility trial of a new 'balanced binocular viewing' treatment for unilateral amblyopia in children age 3-8 years: trial protocol.
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DOI：
10.1136/bmjopen-2021-051423
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发表时间：
2022-05-24
期刊：
影响因子：
2.9
通讯作者：
Dakin SC
中科院分区：
文献类型：
--
作者：
Dahlmann-Noor AH;Greenwood JA;Skilton A;Baker D;Ludden S;Davis A;Dehbi HM;Dakin SC
弱视是儿童中最常见的视力缺陷，治疗弱视的效果往往不理想。闭塞/阿托品模糊是充满了不良的依从性，消退和复发。这些干预措施仅针对弱视眼，未能解决两只眼睛皮层输入的不平衡（“抑制”）。双视治疗操纵双眼视觉体验以重新平衡输入。早期双视疗法的不良依从性启发了我们开发平衡双目观看（BBV），使用电影作为儿童友好的可观看内容。小型观察性研究显示良好的依从性和疗效。需要进行可行性试验以进一步测试安全性并收集设计完整试验所需的信息。我们将在两个地点进行一项观察者屏蔽平行组2a期可行性随机对照试验，将44名3-8岁单侧弱视儿童随机分为BBV组或标准闭塞/阿托品模糊组，分配比例为1:1。我们将在基线、8周和16周时评估视觉功能。主要结果是16周时的干预安全性，以眼间抑制的变化来衡量，被认为是在潜在复视发生之前。次要结局包括其他时间点的安全性、适格性、招募/保留率、依从性、临床结局。我们将总结每组的基线特征，并使用协方差分析评估治疗效果。我们将使用线性混合效应模型比较两组间的连续临床次要终点，并使用描述性统计报告可行性终点。该试验已获得伦敦-布莱顿和苏塞克斯研究伦理委员会（18/LO/1204）、国家卫生服务卫生研究管理局和药品和保健产品监管机构的批准。一个非专业咨询小组将参与向非专业受众提供咨询意见和传播结果，包括在资助者/参与机构的网站上，并就儿童希望我们接触的保健专业受众提供意见。将通过内部和外部会议/会议以及同行评审期刊向临床医生和科学家报告。NCT03754153。
Treatments for amblyopia, the most common vision deficit in children, often have suboptimal results. Occlusion/atropine blurring are fraught with poor adherence, regression and recurrence. These interventions target only the amblyopic eye, failing to address imbalances of cortical input from the two eyes (‘suppression’). Dichoptic treatments manipulate binocular visual experience to rebalance input. Poor adherence in early trials of dichoptic therapies inspired our development of balanced binocular viewing (BBV), using movies as child-friendly viewable content. Small observational studies indicate good adherence and efficacy. A feasibility trial is needed to further test safety and gather information to design a full trial. We will carry out an observer-masked parallel-group phase 2a feasibility randomised controlled trial at two sites, randomising 44 children aged 3–8 years with unilateral amblyopia to either BBV or standard occlusion/atropine blurring, with 1:1 allocation ratio. We will assess visual function at baseline, 8 and 16 weeks. The primary outcome is intervention safety at 16 weeks, measured as change in interocular suppression, considered to precede the onset of potential diplopia. Secondary outcomes include safety at other time points, eligibility, recruitment/retention rates, adherence, clinical outcomes. We will summarise baseline characteristics for each group and assess the treatment effect using analysis of covariance. We will compare continuous clinical secondary endpoints between arms using linear mixed effect models, and report feasibility endpoints using descriptive statistics. This trial has been approved by the London-Brighton & Sussex Research Ethics Committee (18/LO/1204), National Health Service Health Research Authority and Medicines and Healthcare products Regulatory Agency. A lay advisory group will be involved with advising on and disseminating the results to non-professional audiences, including on websites of funder/participating institutions and inputting on healthcare professional audience children would like us to reach. Reporting to clinicians and scientists will be via internal and external meetings/conferences and peer-reviewed journals. NCT03754153.
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