Myopia Control Using Optimized Optical Defocus RCTs

Study Overview
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Brief Summary
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The aims of the study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses.

Detailed Description
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The purpose of the current study is to evaluate whether the DISC3.5 Plus contact lens will slow myopia progression and axial length growth in myopic children as compared with single vision soft contact lenses. The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas. The efficacy of the DISC3.5 Plus lens in slowing myopia progression (change in refractive error) will be compared to a spherical (front and back surface) single vision soft contact lenses in this one-year prospective, randomised and double-masked clinical trial. The hypothesis of this study is that the DISC3.5 Plus will slow myopia progression more than spherical single vision soft contact lenses.

Official Title
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Myopia Control Using Optimized Optical Defocus in Schoolchildren - a Randomized Double Masked Control Trial

Conditions
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Myopia

Intervention / Treatment
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* Device: DISC3.5 plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at enrolment: 8-13 year; Hong Kong Chinese Spherical equivalent refractions (SER): -1.00 to -5.00D Astigmatism: -1.00D or less Anisometropia: 1.25D or less Spectacle corrected monocular visual acuity (VA): 0.0 logMAR or better Contact lens corrected monocular VA: 0.1 logMAR or better Normal binocular function Willingness to wear contact lenses regularly Parents' understanding and acceptance of random allocation of grouping and masking Exclusion Criteria: Prior myopia control treatment, e.g. orthokeratology, defocus soft contact lenses, progressive addition lenses, bifocal lenses, drugs (e.g. atropine), etc. Strabismus or decompensated phoria (checked by cover test at far and near in screening) Known contraindications for contact lens wear Have any ocular and systemic diseases and abnormalities that might affect visual function or refractive development

Ages Eligible for Study
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Minimum Age: 8 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Single vision soft contact lens<br>single vision, spherical soft contact lens | |
| Experimental: DISC3.5 Plus lens<br>A soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas. | Device: DISC3.5 plus<br>* The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic Refraction Change in SER | Change in cycloplegic autorefraction in spherical equivalent (SER) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Axial length (mm) was measured after cycloplegia | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, Myopic Defocus, contact lens, myopia control