jRCT2032220206进行中（未招募）不适用
An evaluation test of Orthokeratology lenses(MCOK-01) for visual acuity correction and myopia control
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 91
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 6age old over 至 12age old under（—）
- 性别
- All
入选标准
- •Subjects who need vision correction for their binoculus due to myopia or mild myopic astigmatism
- •subject who are 6 age over and 12 age under except pre-schoolchild
- •Subjects whose spherical equivalent power of their binoculus is -0.75 to -4.00 D in the cycloplegic objective refraction test
- •Subjects whose cylindrical diopter of their binoculus is -1.50 D or less in the cycloplegic objective refraction test
- •Subjects whose refractive power in the center of the cornea of their binoculus is 39.00 - 48.00D
- •Subject who have healthy eyes that does not show marked fluorescein dyeing in the cornea, over 5 seconds in tear fluid test, are 2,500/mm2 and over in corneal endothelial cell density
排除标准
- •Subject who does not apply to inclusion criteria
- •Subject who does not show informed assent or whose parents does not show informed consent
- •Subject who cannot visit to hospital following schedule
- •Subject with immune disorders (AID, Autoimmune disorders) or diabetes
- •Subject who have possibility to have allergic reaction at ocular surface or eye adnexa or get worse due to wear contact lenses or use care products
- •Subject with acute or subacute inflammation or bacterial, mycotic or viral keratoconjunctivitis
- •Subject with diseases of cornea, conjunctiva or eyelid or damage or odd shape that affect them
- •Subjects with serious dry eye
- •Subject with loosing corneal perception
- •Subjects who show unstable corneal refractive power or very dishonest meyer statue
- •Subject with a history of eye surgery (corneal transplant, detachment of retina, corneal refractive surgery) affect vision after clinical trial
- •Subject who usually use contact lenses
- •Subject whose best corrected vision in subjective refraction test is less than 1.0D
- •Subject whose difference in refractive power between right and left eye is 1.50D and over in the cycloplegic objective refraction test
- •Subject who join other clinical trials or joined that within the past 30days
- •Subject who wore perspective glasses or orthokeratology lenses or had medicine or supplement related with regulatory factors such as atropine in the past
- •Subject who have a plan to go into hospital or have surgery during clinical trials
- •Subject whom An investigator considers that get in on clinical trials is inadequate
结局指标
主要结局
-
Unaided vision Amount of extension of axial length
次要结局
未报告次要终点
研究者
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