Efficacy Study of Different Lens Treatments on Chinese Adolescent Myopia

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of different lens treatments (normal spectacle lens, ortho-K, & Myovision) on myopia control in Chinese adolescent patients.

Detailed Description
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Different lens treatments include normal spectacle lens, orthokeratology, and Myovision (a specially designed spectacle lens commercially available with peripheral defocus controlled as relative myopia). This study is to evaluate the efficacy of these three methods in controlling myopia progression. Until now, there is no sufficient clinical evidences to compare different lens treatments.

Official Title
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Randomized Controlled Trial of Different Lens Treatments on Chinese Adolescent Myopia

Conditions
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Progressive Myopia

Intervention / Treatment
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* Other: Spectacles
* Other: Myovision
* Other: Orthokeratology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescent myopia patients Myopic refraction between -1.00D and -4.50D Astigmatism equal or less than -1.50D Normal break up time of tear film (BUT > 10s) Exclusion Criteria: Existence of any ocular diseases except ametropia Hyperopia Severe dry eye

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spectacles<br>Spectacles are the most common lens treatment to correct myopia. This arm is set to be as a control group for the other two arms. Myopia patients who enter in this group will wear a normal pair of glasses after the baseline examinations (axial length, refraction...). | Other: Spectacles<br>* Normal spectacle lenses were used to correct myopia as the control group.<br>|
| Active Comparator: Myovison<br>Myovision is a kind of specially designed, commercially available spectacle lenses that could control the peripheral refraction of myopia patients. Latest studies have changed the understanding of myopia--correcting both central and peripheral vision during lens treatment is indicating to be an effective way of slowing down eye growth. Patients who entered this group will wear a pair of Myovision after baseline examinations. | Other: Myovision<br>* Myovision is a kind of specially designed spectacle glasses that could control the peripheral refraction of myopia patients. It is commercially available.<br>|
| Active Comparator: Ortho-K<br>Orthokeratology has recently been reported as an effective way to control eye growth for myopia adolescents. Patents who enter this group will wear ortho-K lenses during sleep after baseline examinations. | Other: Orthokeratology<br>* Orthokeratology lenses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Ocular Axial Length | Ocular axial length (AL), which increases with age, will be measured 3 times by an IOLMaster. The first AL examination was considered as the baseline data, and will be repeated 6 and 12 months later. | Baseline, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Spherical Equivalent Refraction | Spherical Equivalent Refraction (SER), which usually changes from time to time, will be measured 3 times by an open field auto-refractometer. The first SER examination was considered as the baseline data, and will be repeated 6 and 12 months later. | Baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lenses, Progressive Myopia, Spectacles