Highly Aspherical Lenslet (HAL) and Binocular Vision (BV) Disorders [HALT X(T) Study]
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To assess the efficacy of HAL lenses in childhood myopia control in children with strabismus and nystagmus
研究概览
简要总结
Assess the effect and changes of eye misalignment (strabismus) with myopia control glasses Assess the efficacy of myopia control glasses on childhood myopia progression in children with strabismus due to the uncertainty clinicians face when prescribing myopia control glasses to these strabismic children
详细描述
Studies have been done to show that spectacles, atropine eye drops, and outdoor activities have some efficacy in slowing myopia progression in children, however most of such studies exclude children with significant eye conditions such as strabismus or nystagmus to isolate the effects of myopia control treatment. In this study, we would like to investigate whether these specialized glasses can effectively slow down the progression of myopia in children with strabismus. Since strabismus can affect visual development, this study would also be able to assess the effect and changes of eye misalignment (strabismus) with myopia control glasses. The study also aims to assess the efficacy of myopia control glasses on childhood myopia progression in children with strabismus due to the uncertainty clinicians face when prescribing myopia control glasses to these strabismic children.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-12 years old Myopia of between -1D and -6D in at least 1 eye Progression of at least 0.5D within the last year Astigmatism less than 2.5D Exotropia Exophoria: horizontal deviation <40PD Esotropia (good control), Esophoria: horizontal deviation <40PD Any vertical strabismus: Vertical deviation <10 PD Intermittent exotropia (good, moderate, poor) Horizontal deviation ≥15 PD, vertical deviation ≤5 PD (?)
排除标准
- •VA poorer than logMAR 0.2 (6/9.5) in either eye Any other ocular condition (e.g. lens opacity, glaucoma) other than myopia, strabismus or nystagmus) Any medical/neurological condition which would interfere with subjects ability to co-operate with tests and attend follow-up appointments.
- •Plans of surgery for strabismus or nystagmus in the next year Constant XT). Past use of any other from of myopia control treatment (eg. atropine or myopia control glasses or contact lenses) within the last year.
研究组 & 干预措施
HALT lenses for children with strabismus
Stellest lenses for children with strabismus
干预措施: HAL lenses for children with strabismus (Device)
SVL for children with strabismus
SVL for children with strabismus
干预措施: SVL for children with strabismus (Device)
结局指标
主要结局
To assess the efficacy of HAL lenses in childhood myopia control in children with strabismus and nystagmus
时间窗: 2 years
a. Efficacy in each eye - i. Primary outcome: change in AL in first vs second 6m ii. Secondary outcome: change in cycloplegic SE \& OCT choroidal thickness b. Alternative analysis: Difference between preferred/non-preferred eye, better-worse squint (size and control at baseline and 6m).
次要结局
- To assess the effect on strabismus (subjectively and functionally) over first vs second 6m(2 years)
研究者
Bryan Sim XR
Consultant
Singapore National Eye Centre