The Different Design of Orthokeratology

Study Overview
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Brief Summary
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In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with binocular myopia up to and including -4.00 D. They were randomly selected to wear both orthokeratology of different designs, one with an aspheric wide inversion zone design in the optical zone and the other with a traditional spherical curved segment design, and to investigate the differences between these two lenses in terms of their effectiveness in myopia retardation, defocus, and aberration.

Official Title
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The Effectiveness and Safety of Different Design of Orthokeratology Lenses to Reduce Myopia Growth

Conditions
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Myopia

Intervention / Treatment
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* Device: Orthokeratology with aspheric wide inversion zone design in the optical zone
* Device: Orthokeratology with traditional spherical design in the optical zone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The age is greater than 8 years and less than 18 years The myopia was within -4.00D (including -4.00D), and the astigmatism was within 1.50D (including 1.50D) in both eyes. Be able to complete 12 months of follow-up They were able to understand the purpose of the trial, volunteered to participate, and signed informed consent by the subjects themselves or their legal guardians Exclusion Criteria: One eye met the inclusion criteria Patients with systemic diseases causing immunocompromised or affecting orthokeratology There are other eye diseases that affect orthokeratology lens wearing, such as dacryocystitis, blepharitis, various inflammation, glaucoma, etc Abnormal cornea Previous corneal surgery or corneal trauma history Active keratitis (e.g., corneal infection) Patients with best corrected distance visual acuity of less than 5.0 Patients with corneal flat curvature lower than 39.00D, or higher than 48.00D Patients with refractive instability Patients with overt strabismus The corneal epithelium showed obvious fluorescent staining, which was not suitable for patients wearing orthokeratology lenses Patients with dry eye are not suitable for orthokeratology Patients with corneal endothelial cell density less than 2000 cells /mm2 Patients who had worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 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: Experimental Group<br> | Device: Orthokeratology with aspheric wide inversion zone design in the optical zone<br>* An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone<br>|
| Active Comparator: Control group<br> | Device: Orthokeratology with traditional spherical design in the optical zone<br>* Subjects wore the orthokeratology with traditional spherical design in the optical zone<br>|
| No Intervention: Blank control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in axial length | Axial length was measured with a biometer | The change of baseline and 1years |