Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06278974
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-19
Brief Title:
Comparing Myopia Treatments in Youth Defocus Spectacles Glasses and Ortho-K
Sponsor:
He Eye Hospital
Organization:
He Eye Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 -100D to -600D 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 Chinas economy and the increasing pressure of childrens 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None