A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improvement in Quality of Life Scores
研究概览
简要总结
The research project titled "A Comparative Study on the Clinical Efficacy, Quality of Life, and Cost of Use of Peripheral Defocus Spectacles, Frame Glasses, and Orthokeratology Lenses in Myopic Children and Adolescents" aims to evaluate different non-surgical myopia correction methods in children. It focuses on assessing the impact of peripheral defocus spectacles, frame glasses, and orthokeratology lenses on the quality of life, clinical effectiveness, and costs associated with each method. The study is a prospective cohort study involving 90 children aged 8-17 years with myopia ranging from -1.00D to -6.00D. It aims to compare the psychological, social, and educational aspects of these correction methods, alongside their costs and clinical outcomes over a period of one year.
详细描述
The research project "Comparison of the clinical effect, quality of life and cost of using defocusing glasses, frame glasses and orthokeratology glasses in children and adolescents with myopia" aims to explore the impact of different myopia correction methods on children and adolescents. Myopia is one of the most common eye diseases in the world, especially in East Asia, where the incidence of myopia is extremely high. With the development of China's economy and the increasing pressure of children's education, the problem of myopia is becoming more and more serious, and parents and teenagers lack sufficient information and evidence for choosing the most suitable correction methods.
This study will compare the defocus frame glasses, ordinary monopteral frame glasses and orthokeratology glasses. The defocusing frame glasses are a new correction method, showing potential in controlling the length of the eye axis. Ordinary single-frame glasses are the most commonly used and economical choice; The orthokeratology lens is a kind of hard contact lens worn at night, which is in fast growing demand in the Chinese market.
The main objectives of the study include:
Quality of life assessment: To explore the impact of different correction methods on adolescents' daily life, learning, movement, appearance, mental health and social activities.
Use cost analysis: Compare the purchase cost, maintenance cost and replacement frequency of defocusing frame glasses, monopter frame glasses and orthokeratology glasses to assess the economic burden of long-term use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7-17 years.
- •Myopia between -1.00D and -6.00D; astigmatism <±1.5D; best corrected visual acuity ≥1.
- •First-time spectacle wearers who use a single correction method and meet the indications for it (any one of orthokeratology lenses, single-vision frame glasses, or myopia control frame glasses)
- •Willing to participate in the entire research process and complete all the examinations, questionnaires and cost records as required.
- •Be able to maintain contact throughout the research period, such as having a fixed address and contact information.
排除标准
- •History of strabismus, amblyopia, refractive disparity or retinal diseases
- •Previous history of eye surgery
- •Severe psychological disorders or behavioral problems
- •History of allergy to contact lenses or contact lens care solutions
结局指标
主要结局
Improvement in Quality of Life Scores
时间窗: 1-Month Follow-up,6-Month Follow-up,12-Month Follow-up
Improvement in Quality of Life Scores: The study will assess the impact of peripheral defocus spectacles, regular frame glasses, and orthokeratology lenses on the improvement of quality of life in myopic children and adolescents. This will be measured using the 'Pediatric Vision-Related Quality of Life Questionnaire' at baseline, 12 months post-treatment to evaluate and compare the long-term effects of these correction methods on quality of life."
Cost-Effectiveness Analysis
时间窗: 6-Month Follow-up,12-Month Follow-up
Cost-Effectiveness Analysis: This secondary outcome will assess the cost-effectiveness of peripheral defocus spectacles, regular frame glasses, and orthokeratology lenses in treating myopia in children and adolescents. The analysis will include the costs of acquiring, maintaining, and replacing these vision correction methods over a period of 12 months. This evaluation aims to provide a comprehensive financial comparison of these methods in terms of long-term expenditure and effectiveness in myopia management.
次要结局
- Clinical Effectiveness Analysis(Baseline,6-Month Follow-up,12-Month Follow-up)