Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults

Study Overview
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Brief Summary
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The aim of this clinical study is to compare the efficacy of DIMS technology spectacle lenses with conventional single vision spectacle lenses at slowing the progression of myopia in the category of children and young adults during three years.

Detailed Description
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The study is non randomized, unmasked, observational and prospective. Participants aged 6-26 with progressing myopia (but no ocular pathology), all Caucasian, are divided in two groups according to single vision spectacle lenses (SV) and DIMS technology lenses (DIMS). The participants are followed during three years (axial length, refraction changes). Defocus incorporated multiple segments (DIMS) spectacle lenses were designed to slow myopia progression in children, based on the principle of peripheral myopic defocus. DIMS spectacles reduce the progression of myopia and reduce axial elongation by 50-60% compared to single vision (SV) lenses according to previous scientific studies conducted mostly on the Asian population under the age of 15. We observe the majority of myopia appears and progresses during childhood. The myopia stabilizes by the age of 18 years, a number of individuals may still present myopic changes. The goals of our study: compare the efficacy of DIMS spectacle lenses with SV spectacle lenses at slowing the progression of myopia in the category of Czech children and young adults (effect on axial length and refractive changes) monitoring axial length and refractive changes in myopic children and young adults (aged 6-26) monitoring adaptation to DIMS lenses in myopes aged 6-26 years monitoring the influence of the environment and individual behavior on the progression of myopia

Official Title
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Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults

Conditions
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Myopia

Intervention / Treatment
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* Other: Single Vision Spectacle Lens
* Other: Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: progressive myopia - Exclusion Criteria: ocular pathology, amblyopia, strabism -

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 26 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Vision Spectacle Lens<br>Participants who chose to correct myopia with single vision spectacle lenses. | Other: Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens<br>* 36 months of therapy<br>|
| Experimental: Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens<br>Participants who chose to correct myopia with DIMS spectacle lenses. | Other: Single Vision Spectacle Lens<br>* 36 months of therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length of eye | biometry (Lenstar 900) | in 36 moths therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective refraction | autorefractometer (Huwitz) | in 36 month therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myopia, axial length, DIMS