JPRN-jRCT2032220206进行中（未招募）3 期
An evaluation test of Orthokeratology lenses(MCOK-01) for visual acuity correction and myopia control
Hiraoka Takahiro0 个研究点目标入组 91 人开始时间: 2022年7月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 91
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 6age old 至 <= 12age old（—）
- 性别
- All
入选标准
- •1) Subjects who need vision correction for their binoculus due to myopia or mild myopic astigmatism
- •2) subject who are 6 age over and 12 age under except pre-schoolchild
- •3) Subjects whose spherical equivalent power of their binoculus is -0.75 to -4.00 D in the cycloplegic objective refraction test
- •4) Subjects whose cylindrical diopter of their binoculus is -1.50 D or less in the cycloplegic objective refraction test
- •5) Subjects whose refractive power in the center of the cornea of their binoculus is 39.00 - 48.00D
- •6) 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
- •1) Subject who does not apply to inclusion criteria
- •2) Subject who does not show informed assent or whose parents does not show informed consent
- •3) Subject who cannot visit to hospital following schedule
- •4) Subject with immune disorders (AID, Autoimmune disorders) or diabetes
- •5) 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
- •6) Subject with acute or subacute inflammation or bacterial, mycotic or viral keratoconjunctivitis
- •7) Subject with diseases of cornea, conjunctiva or eyelid or damage or odd shape that affect them
- •8) Subjects with serious dry eye
- •9) Subject with loosing corneal perception
- •10) Subjects who show unstable corneal refractive power or very dishonest meyer statue
- •11) Subject with a history of eye surgery (corneal transplant, detachment of retina, corneal refractive surgery) affect vision after clinical trial
- •12) Subject who usually use contact lenses
- •13) Subject whose best corrected vision in subjective refraction test is less than 1.0D
- •14) Subject whose difference in refractive power between right and left eye is 1.50D and over in the cycloplegic objective refraction test
- •15) Subject who join other clinical trials or joined that within the past 30days
- •16) Subject who wore perspective glasses or orthokeratology lenses or had medicine or supplement related with regulatory factors such as atropine in the past
- •17) Subject who have a plan to go into hospital or have surgery during clinical trials
- •18) Subject whom An investigator considers that get in on clinical trials is inadequate
研究者
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