NCT06037850已完成不适用
Clinical Trial of Orthokeratology Lens (MCOK-01)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 6
- 主要终点
- Axial length
研究概览
简要总结
A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens
详细描述
The test product is the orthokeratology lens, and the control product is a commercially available orthokeratology lens. The number of enrolled subjects is 390, and clinical observation is performed for 12 months.
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
- 6 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with myopia and myopic astigmatism
- •Those who are not willing to wear glasses in daily life
- •Fully understand of the purpose of the clinical trial and agree to sign the informed consent form to participate in clinical trials, based on his/her willingness
- •Those who can visit the institution on scheduled dates
- •Those who can receive guidance and tests as required by the investigator
- •Those who fully understand and follow the instructions of the lenses for this clinical trial
排除标准
- •<At screening>
- •Best corrected vision acuity of less than 0.8 with spectacles
- •Subjective refraction test shows spherical power greater than -6.00D，less than -0.50D or astigmatism greater than 1.5D
- •Patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses)
- •The medical history of intraocular surgery that may affect the effect of wearing the lens for this clinical trial (those with corneal transplantation, Retinal detachment, etc.)
- •The medical history of refractive corneal surgery
- •Those in need of a strength out of the scope of lens for this clinical trial
- •Having eye allergic diseases that may cause disorders in wearing the lenses for this clinical trial
- •All Corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, acute dry eyes, low corneal endothelial cell counts.
- •Pregnant (judgment according to her known information) or those who plan to become pregnant during clinical trial, or those who are breast feeding
- •Those who are participating in other clinical trials or have participated in other clinical trial in the past 30 days
- •Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days
- •Prior experience with myopia control treatment (e.g. atropine, orthokeratology, multifocal soft contact lenses)
- •Minor/adult subjects who lack mental capacity
- •Other not suitable for this clinical trial at investigator's discretion <At the beginning of the wearing>
- •(1) Those who are determined to be unable to obtain good centralized positioning even though changing strength (2) Pregnancy confirmed (3) Those who are difficult in continuing the clinical trial at investigator's discretion
结局指标
主要结局
Axial length
时间窗: 1 year
axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS)
Refraction
时间窗: 1 year
spherical and cylinder power in diopter for best corrected visual acuity measured subjectively
Visual acuity
时间窗: 1 year
uncorrected visual acuity measured using logMAR chart
次要结局
- Adverse Events(1 year)
研究者
研究点 (6)
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