A Pilot Evaluation of Refractive Error Progression in Pre-Myopic Children in Singapore With and Without Myopia Control Spectacles
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change in cycloplegic objective spherical equivalent refractive error (dioptres) with ZEISS MyoActive spectacle lenses compared to plano single vision (SV) spectacles at 12 months.
研究概览
简要总结
This study aims to find out whether ZEISS MyoActive lenses can help prevent short-sightedness from developing in children. We aim to recruit at least 50 children in total for this study.
Myopia (short-sightedness) is becoming increasingly common in children worldwide. Early onset of myopia often leads to faster progression and a higher chance of developing high myopia, which increases the risk of serious eye conditions that can affect vision in adulthood, such as retinal detachment, glaucoma, and cataracts. Current treatments can slow the worsening of short-sightedness once children become myopic, but there is limited evidence on whether early intervention can delay myopia from developing in the first place.
This study will compare two types of commonly used spectacle lenses:
ZEISS MyoActive lenses, which are designed to provide a type of optical signal that may reduce the worsening of short-sightedness; and Standard single-vision lenses, which are the usual lenses prescribed for clear vision.
Children who join the study will be randomly assigned to wear one of these two lens types for 12 months. They will attend regular check-ups during this time so we can monitor their eye health and vision.
By randomly assigning children to one of these two lens types and following them over 12 months, we aim to determine whether ZEISS MyoActive lenses:
reduce the likelihood of developing short-sightedness, slow changes in how short-sighted a child's eyes are becoming and eye growth, and are safe, comfortable, and well-tolerated for everyday use. The findings from this study may help improve early myopia prevention strategies and potentially reduce future risks of high myopia and its associated eye conditions.
详细描述
Myopia is a 'global epidemic' owing to its rapid rise in prevalence across the world. Half of the world's population is expected to be myopic by the year 2050. Myopia significantly affects the quality of life of an individual and is an economic burden to both the individual and the society on account of the costs involved in living with myopia. In addition, high myopia increases the risk of ocular morbidity such as retinal detachment, cataract, glaucoma which could lead to blindness. Several optical and pharmaceutical strategies developed over the recent years have been shown to control or slow the progression of myopia.
However, there remains a critical knowledge gap in our understanding of refractive error progression during the pre-myopic phase, a period that precedes the onset of clinically manifest myopia and may represent a key window for early intervention. As such, increasing attention has been directed towards identifying children at risk of developing myopia and implementing preventive strategies before myopia onset, including those summarized in the IMI interventions for controlling myopia onset. Although it has been reported that interventions in the pre-myopic phase can be successful in slowing refractive error shift, much work remains to understand ocular development during this phase, and particularly the needs and motivation of pre-myopic children and their carers. For example, since the eye is not yet myopic, this group may demonstrate lower compliance with any prescribed modality. Furthermore, given the young age of this cohort (commonly 4 to 6 years in East Asia), there may be specific requirements that need to be better understood. In particular, the potential role of myopia control spectacle lenses, as highlighted in the IMI recommendations, in influencing refractive development in pre-myopic children remains inadequately explored. Understanding whether such optical interventions can modify refractive trajectories in this at-risk population may have important implications for early myopia prevention strategies.
HYPOTHESIS AND OBJECTIVES
We hypothesise that pre-myopic children randomised to ZEISS MyoActive lenses will demonstrate a reduced rate of progression to clinical myopia, defined by cycloplegic spherical equivalent ≤ -0.50 D, compared with children wearing single-vision spectacle lenses over the study duration.
Primary Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants enrolled in the trial must:
- •be accompanied by a parent or guardian who is able to read and comprehend English and sign a record of informed consent/assent;
- •be able to understand and participate in the Assent process;
- •at baseline, be within the age range of 6 to 12 years old inclusive;
- •No prior spectacle correction
- •Cycloplegic spherical equivalent (SE) 0.00 to + 2.00 D
- •Astigmatism of less than -1.50D
- •Anisometropia of not more than 1.50D
- •At least 1 parent or more with myopia
排除标准
- •Participants enrolled in the trial must NOT have:
- •Any pre-existing systemic or ocular condition, including infection or disease that is likely to affect visual acuity and refractive error;
- •Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus.
- •Use of or a need for any systemic medication or topical medications which may alter normal ocular findings / are known to affect a participant's ocular health / physiology in an adverse or beneficial manner at enrolment and/or during the study. NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the study product is used.
- •History of eye trauma
- •Amblyopia
- •Strabismus
- •History of any form of optical correction
- •Any concomitant myopia control treatment including atropine eyedrops, contact lenses or other myopia control glasses.
- •The Investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the study requirements or it is believed to be in the participant's best interests.
研究组 & 干预措施
Placebo
Participants will be provided with a pair of spectacles fitted with plano single vision lenses according to the assigned study intervention.
干预措施: Single Vision Lenses (Device)
Zeiss MyoActive Lenses
Participants will be provided with a pair of spectacles fitted with plano MyoActive lenses according to the assigned study intervention.
干预措施: Zeiss MyoActive lenses (Device)
结局指标
主要结局
Change in cycloplegic objective spherical equivalent refractive error (dioptres) with ZEISS MyoActive spectacle lenses compared to plano single vision (SV) spectacles at 12 months.
时间窗: 12 months of wear
次要结局
- Change from baseline in axial length (mm) with ZEISS MyoActive spectacle lenses compared to single vision (SV) control lenses at 12 months.(12 months)
- Motivation to use myopia control interventions in carers of children with pre-myopia as assessed by motivation questionnaire at 12 months.(12 months)
- Compliance with ZEISS MyoActive spectacle lens wear in children with pre-myopia, as measured by patient reported questionnaire at 12 months(12 months)
- Change from baseline in choroidal thickness (µm) in children wearing ZEISS MyoActive spectacle lenses compared to single vision lenses at 12 months.(12 months)
- Number of participants with adverse events related to ZEISS MyoActive spectacle lens wear compared to single vision lenses at 12 months.(12 months)
- Adherence to ZEISS MyoActive spectacle lens wear compared to single vision lenses, as measured by patient reported questionnaire at 12 months.(12 months)
- Change from baseline in quality of life scores in children wearing ZEISS MyoActive spectacle lenses compared to single vision lenses, as assessed by tolerability questionnaire at 12 months.(12 months)
研究者
Foo Li Lian
Clinical Director, Myopia Service, Singapore National Eye Centre, Myopia Centre of Excellence Singapore Clinical Assistant Professor, DUKE-NUS Graduate Medical School Consultant Ophthalmologist, Singapore National Eye Centre Myopia Program Lead, SNEC
Singapore National Eye Centre