the Comparison of Multifocal Contact Lenses and Bifocal Spectacles for Congenital Cataracts
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Demography (age, sex, laterality and medical history)
研究概览
简要总结
In this study, the investigators provide participants who had congenital cataract the multifocal contact lenses and bifocal spectacles in the purpose of seeking out a better way to make a definite diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of multifocal contact lenses and bifocal spectacles.
详细描述
Children diagnosed as cataract without treatment were enrolled to a prospective, randomized controlled study. Patients were assigned to four groups: participants in group A wearing multifocal contact lenses a week and then bifocal spectacles a week;in Group B, the participants wearing bifocal spectacles a week and then multifocal contact lenses;in Group C, the participants wearing multifocal contact lenses four a year;in Group D, the participants wearing bifocal spectacles four a year. Investigators compare the acuity, refraction, contrast sensitivity and the results of questionnaire between A and B , C and D groups.
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
- None
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as binocular cataract
- •after the surgery of binocular intraocular lens implantation more than one month
排除标准
- •diagnosed as xerophthalmus
- •diagnosed as other eye diseases or systemic diseases
结局指标
主要结局
Demography (age, sex, laterality and medical history)
时间窗: baseline
The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.
次要结局
- contrast sensitivity(after wearing contact lenses one month, three months ,six months and a year)
- The refraction status (presented as spherical equivalent, SE)(after wearing contact lenses one month, three months ,six months and a year)
- questionnaire result(after wearing contact lenses one month, three months ,six months and a year)
- acuity(after wearing contact lenses one month, three months ,six months and a year)
研究者
Haotian Lin
Clinical Professor
Sun Yat-sen University