Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group

Study Overview
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Brief Summary
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The purpose of this study is to examine the efficacy and performance of the Defocus Incorporated Multiple Segments (DIMS) Spectacle lenses on controlling myopia progression in fast progressing myopic children.

Detailed Description
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DIMS spectacle lens is a multifocal spectacle lens that produces myopic defocus images and corrects distance refractive errors at the same time. Participants will be prescribed a pair of DIMS spectacle lenses. Their cycloplegic refraction and axial length will be monitored every 6 months over 2 years.

Official Title
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Effectiveness of the Defocus Incorporated Spectacle Lenses on Fast Progressing Myope - Auxiliary Group

Conditions
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Myopia

Intervention / Treatment
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* Other: DIMS spectacle lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SER: -1.00D or below Documented history of fast progressing myopia, either in SER or AL SER progression: 0.50D/year or more AL elongation: 0.27mm/year or more Best-corrected monocular visual acuity (VA) in both eyes: 0.00 logMAR (equivalent) or better Acceptance of random group allocation and the masked study design Anisometropia of 1.50 D or less Astigmatism of 2.00 D or less Exclusion Criteria: Strabismus and binocular vision abnormalities Ocular and systemic abnormalities Prior experience of myopia control

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 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
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DIMS lens group<br>Participants will be prescribed with a pair of DIMS spectacle lenses for 24 months. | Other: DIMS spectacle lens<br>* DIMS spectacle lens is a multifocal spectacle lens that corrects the distance refraction and provides myopic defocus simultaneously.<br>* Other names: MiYOSMART;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycloplegic refraction change in spherical equivalent refraction (SER) | Cycloplegic SER (in diopter) will be measured using an open field autorefractor. Change in SER with cycloplegia from the baseline over a first 12-month period and a 12-month period of follow-up will be measured. | Baseline, 1st year and 2nd year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length change | Axial length (mm) will be measured after cycloplegia using a non-contact optical biometer. Change in axial length from the baseline over a first 12-month period and a 12-month period of follow-up will be measured. | Baseline, 1st year and 2nd year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, Defocus