Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

Study Overview
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Brief Summary
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Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia

Detailed Description
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Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively. Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.

Official Title
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Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

Conditions
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Myopia

Intervention / Treatment
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* Device: Circular cylindrical mirror modulated frame glasses (compact)
* Device: Circular cylindrical mirror modulated frame glasses (strong defocus)
* Device: single vision frame glasses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6-13 years old; SER: -0.75 to -5.00 dioptres (D). Astigmatism and anisometropia of 1.50 D or less; Monocular best corrected visual acuity (VA) of 1.0 or better; Acceptance of random group allocation and the masked study design Voluntarily participate in the clinical trial and sign the informed consent; Exclusion Criteria: Strabismus. Ocular and systemic abnormalities. Prior experience of myopia control. Only one eye meets the inclusion criteria.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 13 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Circular cylindrical mirror modulated frame glasses (compact)<br>Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (compact) throughout the entire course of the study. | Device: Circular cylindrical mirror modulated frame glasses (compact)<br>* Circular cylindrical mirror modulated frame glasses (compact)<br>|
| Experimental: Circular cylindrical mirror modulated frame glasses (strong defocus)<br>Subjects that were randomized to receive the Circular cylindrical mirror modulated frame glasses (strong defocus) throughout the entire course of the study. | Device: Circular cylindrical mirror modulated frame glasses (strong defocus)<br>* Circular cylindrical mirror modulated frame glasses (strong defocus)<br>|
| Experimental: single vision frame glasses<br>Subjects that were randomized to receive the single vision frame glasses throughout the entire course of the study. | Device: single vision frame glasses<br>* single vision frame glasses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in ocular axial length in a year | The ocular axial length was measured by AL-scan | baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cycloplegic objective spherical equivalent in a year | The cycloplegic objective spherical equivalent was evaluated by a autorefractor | baseline, 12 months |