WEAR (Wearability and Evaluation of Adjustable Refraction) III: A Randomized Non-inferiority Trial of Children's Wear of Adjustable Glasses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 主要终点
- Wearing spectacles proportion
研究概览
简要总结
Two-month randomized trial comparing three groups.
详细描述
Two-month randomized non-inferiority trial (the margin of non-inferiority is 20%) comparing three groups: self-refraction with adjustable glasses, receiving adjustable glasses; subjective refraction by an expert refractionist after computer optometry and receiving custom standard glasses; subjective refraction by an expert refractionist after computer optometry and receiving ready-made glasses. The main outcome of this study is the rate of glasses wear on twice-weekly covert evaluation by head teachers. And the continuous teacher assessment of wearing study glasses will be calculated as the number of times wearing glasses/ Total number of separate observations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •11-16 years old middle school students from two locations in Guangdong Province.
- •With ≤ -1.00 Diopter of myopic refractive error in each eye.
- •With uncorrected vision ≤ 6/12 in both eyes thought to be due to refractive error (that is, correctable to at least 6/7.5 with subjective refraction by an optometrist).
- •With informed consents(There are two types of informed consents. One of them is whether the parents of the students agree their kids to participate in the project. The other informed consent is whether the parents agree their kids to have the cycloplegic refraction. If the students were admitted to participate in project but without being agreed to have cycloplegic refraction by their parents , they would have non cycloplegic retinoscopy.).
排除标准
- •Those corrected VA can not up to 6/7.5 with subjective refraction by an optometrist.
- •Those with significant strabismus or vision abnormality (keratopathy, cataract, vitreous macular diseases ), or with vision deficiency ( amblyopia ) children are to be excluded.
- •Children developing acquired vision problems other than myopia.
研究组 & 干预措施
Group 1
Self-refraction with adjustable glasses
干预措施: Adjustable glasses (Other)
Group 2
Subjective refraction by an expert refractionist after auto refraction and receiving custom standard glasses
干预措施: Custom standard glasses (Other)
Group 3
Subjective refraction by an expert refractionist after auto refraction and receiving ready-made glasses
干预措施: Ready-made glasses (Other)
结局指标
主要结局
Wearing spectacles proportion
时间窗: 5 months after the start of the project
The participators in each group may have the different wearing spectacles proportion.
次要结局
- The quality of life after wearing glasses(questionnaires)(5 months after the start of the project)
研究者
Congdon Nathan
Professor, MD,MPH
Sun Yat-sen University