Clinical trial NCT06278974: Comparing Myopia Treatments in Youth: Defocus Spectacles, Glasses, and Ortho-K
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myopia
Cost-effectiveness Analysis
Quality of Life
Keywords: Myopia
youth
glasses
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises children and adolescents aged 13-17 years with myopia ranging from -1.00D to -6.00D and astigmatism less than ±1.5D. Participants are first-time wearers of either peripheral defocus spectacles, single-vision frame glasses, or orthokeratology lenses. They are willing and able to complete all study requirements, including examinations, surveys, and cost recordings, and can maintain contact throughout the study duration with a stable address and contact information.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Improvement in Quality of Life Scores
timeFrame: 1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up
measure: Cost-Effectiveness Analysis
timeFrame: 1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up
Secondary outcomes:
measure: Clinical Effectiveness Analysis
timeFrame: Baseline,1-Month Follow-up,3-Month Follow-up,6-Month Follow-up,12-Month Follow-up
Other outcomes:
Locations:
city: Shenyang
country: China
facility: HeEyeHospital
state: Liaoning
Study officials:
affiliation: He Eye Hospital
name: ruyi Li
role: PRINCIPAL_INVESTIGATOR
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