Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K
- Conditions
- Cost-effectiveness AnalysisQuality of LifeMyopia
- Registration Number
- NCT06278974
- Lead Sponsor
- He Eye Hospital
- Brief Summary
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 300 children aged 13-17 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.
- Detailed Description
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.
In addition, the study will comprehensively evaluate the differences in clinical effectiveness, quality of life and cost of use of these correction methods, providing parents and adolescents with more comprehensive and objective information to help them make more informed choices.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Children aged 13-17 years.
- Myopia between -1.00D and -6.00D; astigmatism <±1.5D; best corrected visual acuity ≥1.0.
- No prior use of peripheral defocus spectacles, single-vision frame glasses, or orthokeratology lenses (meaning first-time wearers).
- Willingness to participate in the entire study process, completing all examinations, surveys, and cost recordings as required.
- Ability to maintain contact throughout the study, with a fixed address and contact information.
- Other eye conditions: history of strabismus, amblyopia, anisometropia, fundus diseases, dry eye, etc.
- Allergies: history of allergies to certain materials or medications.
- Surgical history: recent eye surgery.
- Non-compliance with required wear, follow-up, or lack of cooperation.
- Severe psychological disorders or behavioral problems.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cost-Effectiveness Analysis 1-Month Follow-up,3-Month Follow-up,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.
Improvement in Quality of Life Scores 1-Month Follow-up,3-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."
- Secondary Outcome Measures
Name Time Method Clinical Effectiveness Analysis Baseline,1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up "Clinical Effectiveness Analysis: The study will evaluate the differences in vision correction effectiveness among peripheral defocus spectacles, regular frame glasses, and orthokeratology lenses in myopic children and adolescents. This includes vision tests (such as standard visual acuity charts) and ocular assessments to measure changes in axial length. These evaluations will be conducted at baseline, 6 months, and 12 months post-treatment to compare and analyze the clinical effectiveness of the various correction methods.
Trial Locations
- Locations (1)
HeEyeHospital
🇨🇳Shenyang, Liaoning, China