The Early Glasses Study: Can Early Glasses Prevent the Development of Amblyopia in Children With High Refractive Errors at Age One
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 601
- 试验地点
- 1
- 主要终点
- The occurrence of amblyopia at the final examination, stratified according to visual acuity of the amblyopic eye in the intervention group (group 1) and in the control group (group 2)
研究概览
简要总结
In a randomized controlled trial, we will establish whether early glasses for high refractive error at age one reduce the development of amblyopia between age one and four. As a secondary outcome early literacy will be compared in groups with and without glasses.
详细描述
Background of the study:
Amblyopia (prevalence approx. 3.4%) develops in early childhood when the child's eyes have severe refractive error, when they squint, or both. It can effectively be treated with glasses and patching the better eye, but treatment should start before age 6 to be effective. Therefore, visual acuity should be measured in all children aged 4-5 to detect amblyopia early enough. In an effort to prevent the development of amblyopia all together, in some countries devices are being used to measure refractive error in toddlers and, when refractive error is severe, fit them glasses before amblyopia develops. In Flanders, the measurement of refractive error in 1- and 2.5-year-olds began in 2012, in addition to regular vision screening with measurement of the visual acuity at the age of 3, 4 and 5. Between 2012 and 2017 the percentage of 4-year-old glasses wearing children had risen from 4.7% to 6.4%, but it was unknown how many cases of amblyopia had been prevented from developing. A prospective comparison seems warranted between this new method and the current national vision screening program in the Netherlands.
Objective of the study:
To investigate whether treating children with high refractive errors at age one with glasses prevents the development of amblyopia.
Study design:
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will only have access to coded data, which cannot be traced back to the individual participants, from the electronic Case Report Forms in Castor, a cloud-based clinical data management platform.
入排标准
- 年龄范围
- 12 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Registered at one of the participating CHCs;
- •12-18 months of age;
- •Voluntary approval for participation by the parents or legal representative/guardian with provided written informed consent;
- •Willingness of the parents/guardian(s) to comply with the study procedures
排除标准
- •Congenital syndromes;
- •Psychomotor retardation;
- •Known hereditary defects;
- •Known cardiac disease;
- •Severe comorbidity;
- •Children's whose parents do not agree to cyclopegia with the use of cyclopentolate 1% eye drops for orthoptic examination (retinacopy) by the study orthoptist;
- •Refractive error higher than the AAPOS criteria twofold (i.e. hyperopia >7 dioptres, anisometropia >3 dioptres and astigmatism of >3 dioptres at 90º or 180º and >2 dioptres in oblique axis (>10º eccentric to 90º or 180º);
- •Strabismus;
- •Amblyopia;
- •Cataract or other media opacity;
- •Other ophthalmic disease requiring immediate referral;
研究组 & 干预措施
Group 1 - High refractive error: Intervention
Children with high refractive error (i.e. exceeding the AAPOS 2003 criteria) at age one, who are randomly assigned to the intervention group
干预措施: Orthoptic care with the prescription of glasses from age 12-18 months onwards (Other)
Group 2 - High refractive error: Control
Children with high refractive error (i.e. exceeding the AAPOS 2003 criteria) at age one, who are randomly assigned to the control group
干预措施: Orthoptic care without the prescription of glasses from age 12-18 months onwards (Other)
Group 3 - Mild or no refractive error
Children with mild or no refractive error (i.e. not exceeding the AAPOS 2003 criteria) at age one
干预措施: First measurement only (Other)
结局指标
主要结局
The occurrence of amblyopia at the final examination, stratified according to visual acuity of the amblyopic eye in the intervention group (group 1) and in the control group (group 2)
时间窗: Final examination, time = 30-36 months
The prevalence of amblyopia at age 4 stratified according to visual acuity of the amblyopic eye in the intervention group (group 1) and the control group (group 2) at the final examination. When a child is diagnosed with amblyopia during the course of the study, the child's visual acuity at the moment of referral will be used as primary outcome, after correcting for age.
次要结局
- In all groups, occurrence of strabismus at the final examination(Final examination, time = 30-36 months)
- Prevalence of amblyopia at age 1(First examination, time = 0)
- Occurrence of amblyopia at age 4 stratified according to visual acuity of the amblyopic eye at the final examination in the children without refractive error at age 1 (group 2 and 3).(Final examination, time = 30-36 months)
- Type and magnitude of refractive error at age 1(First examination, time = 0)
- Pre-literacy skills in the intervention and control group at age 4(Final examination, time = 30-36 months)
研究者
Huib Simonsz
Principal Investigator, MD, PhD
Erasmus Medical Center