The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in axial length
研究概览
简要总结
In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The age is greater than 8 years and less than 18 years
- •The myopia was within -4.00D (including -4.00D), and the astigmatism was within 1.50D (including 1.50D) in both eyes.
- •Be able to complete 12 months of follow-up
- •They were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians
排除标准
- •One eye met the inclusion criteria
- •Patients with systemic diseases causing immunocompromised or affecting orthokeratology
- •There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc
- •Abnormal cornea
- •Previous corneal surgery or corneal trauma history
- •Active keratitis (e.g., corneal infection)
- •Patients with best corrected distance visual acuity of less than 5.0
- •Patients with corneal flat curvature lower than 39.00D, or higher than 48.00D
- •Patients with refractive instability
- •Patients with overt strabismus
- •The corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses
- •Patients with dry eye are not suitable for orthokeratology
- •Patients with corneal endothelial cell density less than 2000 cells /mm2
- •Patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days
研究组 & 干预措施
Experimental Group
干预措施: Orthokeratology with aspheric wide inversion zone design in the optical zone (Device)
Control group
干预措施: Orthokeratology with traditional spherical design in the optical zone (Device)
Blank control group
结局指标
主要结局
Changes in axial length
时间窗: The change of baseline and 1years
Axial length was measured with a biometer
次要结局
未报告次要终点