Clinical Trial of Orthokeratology Lens (MCOK-01)

Study Overview
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Brief Summary
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A prospective, multicenter, randomized, controlled clinical trial of orthokeratology lens

Detailed Description
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The test product is the orthokeratology lens, and the control product is a commercially available orthokeratology lens. The number of enrolled subjects is 390, and clinical observation is performed for 12 months.

Official Title
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Clinical Trial of Orthokeratology Lens (MCOK-01)

Conditions
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Myopia

Intervention / Treatment
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* Device: Test orthokeratology lens
* Device: Control orthokeratology lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with myopia and myopic astigmatism Those who are not willing to wear glasses in daily life Fully understand of the purpose of the clinical trial and agree to sign the informed consent form to participate in clinical trials, based on his/her willingness Those who can visit the institution on scheduled dates Those who can receive guidance and tests as required by the investigator Those who fully understand and follow the instructions of the lenses for this clinical trial Exclusion Criteria: <At screening> Best corrected vision acuity of less than 0.8 with spectacles Subjective refraction test shows spherical power greater than -6.00D，less than -0.50D or astigmatism greater than 1.5D Patients in need of treatment for eye disease other than refractive error (excluding those receiving artificial tears eye drops due to the wearing of corneal contact lenses) The medical history of intraocular surgery that may affect the effect of wearing the lens for this clinical trial (those with corneal transplantation, Retinal detachment, etc.) The medical history of refractive corneal surgery Those in need of a strength out of the scope of lens for this clinical trial Having eye allergic diseases that may cause disorders in wearing the lenses for this clinical trial All Corneal abnormalities including keratoconus, corneal dystrophy, previous history of ocular herpes infections, acute dry eyes, low corneal endothelial cell counts. Pregnant (judgment according to her known information) or those who plan to become pregnant during clinical trial, or those who are breast feeding Those who are participating in other clinical trials or have participated in other clinical trial in the past 30 days Prior experience with use of rigid lenses within the previous 3 weeks or use of soft lenses within the previous 3 days Prior experience with myopia control treatment (e.g. atropine, orthokeratology, multifocal soft contact lenses) Minor/adult subjects who lack mental capacity Other not suitable for this clinical trial at investigator's discretion <At the beginning of the wearing> (1) Those who are determined to be unable to obtain good centralized positioning even though changing strength (2) Pregnancy confirmed (3) Those who are difficult in continuing the clinical trial at investigator's discretion

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Randomized to Treatment | Device: Test orthokeratology lens<br>* Randomized to test orthokeratology lens worn during sleep every night<br>|
| Active Comparator: Control<br>Randomized to Control | Device: Control orthokeratology lens<br>* Randomized to control orthokeratology lens worn during sleep every night<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | uncorrected visual acuity measured using logMAR chart | 1 year | 
| Axial length | axial eye length in millimeter measured by MYAH (Topcon) and IOL master (ZEISS) | 1 year | 
| Refraction | spherical and cylinder power in diopter for best corrected visual acuity measured subjectively | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse events are classified into moderate, middle, or severe. | 1 year |