Effect of Orthokeratology Versus Spectacles on Myopia Progression in Chinese Children: A Crossover Trial

Study Overview
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Brief Summary
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Orthokeratology is becoming popular for the treatment of myopia children. Many studies have shown that orthokeratology is effective in temporarily reducing refractive error, and is also helpful for controlling myopia progression. However, the mechanism for its slowing myopia progression and rebound effect after the treatment have not been clearly studied. In addition, the effect of orthokeratology among Chinese children has not been evaluated with randomized controlled trial.This study is to assess the effect of orthokeratology versus spectacles on myopia progression in school-aged Chinese children during two years.

Official Title
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Effect of Orthokeratology on Myopia Progression in Chinese Children

Conditions
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Myopia

Intervention / Treatment
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* Device: Orthokeratology
* Device: Spectacle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages Eligible for Study: 7 Years to 14 Years Genders Eligible for Study: Both Visual acuity 20/20 or better in each eye Spherical error ranging from -0.5 D to -5.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development Exclusion Criteria: Currently or history using other interventions to control myopia progression (acupuncture, drugs, contact lens, ear needles and so on) Unable to cooperate with the ocular examination,questionnaire survey,or orthokeratology wearing

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orthokeratology in the first year<br>The participants would wear orthokeratology in the first year and then switch to spectacle in the second year | Device: Orthokeratology<br> <br> Device: Spectacle<br> <br> * Other names: Glasses;|
| Active Comparator: Spectacle in the first year<br>The participants would wear spectacle in the first year and then changed to orthokeratology in the second year | Device: Orthokeratology<br> <br> Device: Spectacle<br> <br> * Other names: Glasses;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refraction | The participants will be measured for their cycloplegic central refractive error before and after wearing the orthokeratology. Peripheral refraction will also be measured by WAM-5500. | Change from baseline at 1 year | 
| Axial length | The Lenstar will be used to measure the axial length. | Change from baseline at 1 year | 
| Refraction |  | Change from baseline at 2 years | 
| Axial length |  | Change from baseline at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film break up time(BUT) |  | Change from baseline at 1 year | 
| Self evaluation of comfortableness |  | Change from baseline at 1 year | 
| Corneal endothelial cell density |  | Change from baseline at 1 year | 
| Tear film break up time(BUT) |  | Change from baseline at 2 years | 
| Self evaluation of comfortness |  | Change from baseline at 2 years | 
| Corneal endothelial cell density |  | Change from baseline at 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthokeratology, Myopia progression