Efficacy and Visual Quality of Orthokeratology Lenses With Different Designs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in axial length
研究概览
简要总结
Orthokeratology (ortho-k) lens is very effective in slowing down axial elongation in myopic children by 30% to 63% when compared to children wearing single-vision spectacles or contact lenses. More recently, it is reported that the children wearing orthok lens of smaller back optical zone diameter (BOZD) demonstrated a smaller axial elongation when compared to children wearing lens with larger BOZD. We aimed to explored the myopia efficacy and visual quality of ortho-k with different BOZD (5.0mm or 6.2mm).
详细描述
This prospective study aimed to evaluate the efficacy of orthokeratology lenses with different back optical zone diameters (BOZD) in slowing axial elongation. Additionally, visual quality will be assessed through measurements of wavefront aberrations, contrast sensitivity, and subjective visual quality using a validated questionnaire. The study seeks to explore the effectiveness of various Ortho-K lens designs and the potential factors influencing their outcomes.
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 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 8 and 13 years.
- •Subjective refraction under cycloplegia: spherical power between -4.00 D and
- •1.00 D, with cylindrical power≤ 1.50 D.
- •Best-corrected visual acuity (BCVA) of ≥ 1.0 based on subjective refraction.
- •Willing to participate in the clinical trial and provide signed informed consent.
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
Myopic children who need OK lens treatment
干预措施: Orthokeratology with 5.0mm back optical zone diameter (Device)
Control group
Myopic children who need OK lens treatment
干预措施: Orthokeratology with a 6.2 mm back optical zone diameter (Device)
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
研究者
Xiaoyan Yang
Tianjin Eye Hospital
Tianjin Eye Hospital