Accrued Effect of Orthokeratology for Myopia Control in Children and the Effectiveness of Myopia Control Using an Innovative Orthokeratology Modality. Experiment 2. Effect in New Ortho-k Wearers
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Back Surface Lens Deposits
研究概览
简要总结
The two-year prospective study aims at investigating frequently replacement effect on myopia control in young children, and the use of weekly protein removal system in monthly replacement modality orthokeratology lenses on surface deposit.
详细描述
In this two-year prospective study, low myopic children, aged 6-8 years, who have no prior experience in contact lens wear and myopia control treatment will be recruited. They will be prescribed with monthly replacement orthokeratology lenses for a period of one year. Axial elongation and ocular conditions during the study will be determined. Subjects will be randomly assigned to normal cleaning and intensive cleaning groups. Subjects in normal cleaning group will be provided with complimentary contact lenses solutions for daily cleaning and disinfection. In addition to the daily procedures for lens case, subjects in the intensive cleaning group will be required to perform weekly protein removal.
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
- Single (Outcomes Assessor)
盲法说明
Independent examiners will be responsible for the assessment of the primary outcomes, which are the axial length and surface coating.
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 6-10 years
- •Normal ocular and general condition and not on medication which may contraindicate ortho-k lens wear
- •Refractive sphere between -0.75 to -4.00 D, refractive cylinder ≤ -1.50 D and anisometropia ≤ -1.00 D
- •Best correctable vision better than 0.08 logMAR in the worse eye
- •Normal binocular function and accommodative status
- •No prior experience in contact lens wear and myopia control treatment
排除标准
- •Strabismus at distance or near
- •Contraindication for ortho-k lens wear
- •Prior history of ocular surgery, trauma, or chronic ocular disease
- •Systemic or ocular conditions that may interfere refractive development
- •Systemic or ocular conditions that may interfere tear quality and contact lens wear
- •Poor response to the use of study lenses
- •Poor compliance to test procedures
- •Poor compliance to the use of ortho-k lenses (e.g. use of solution, use of lenses)
- •Poor compliance to follow-up schedule
结局指标
主要结局
Changes in Back Surface Lens Deposits
时间窗: Every month up to 24 months
Surface deposits will be graded using a 4-point scale: 0=no deposit; 1=mild; 2=moderate; 3=severe
Axial elongation in 2 years
时间窗: 12 months
Elongation of the eyeball in 24 months
次要结局
- Number of participants with serious adverse effects in 2 years(24 months)
研究者
Pauline Cho
Professor
The Hong Kong Polytechnic University