Myopia Assessment of Two Manufacturing Processes

Study Overview
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Brief Summary
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Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.

Official Title
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Myopia Assessment of Two Manufacturing Processes for Myopia Management Lenses (MAPLE)

Conditions
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Juvenile Myopia

Intervention / Treatment
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* Device: SightGlass Vision DOT Spectacle Lenses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between the ages of 6 and 14 years old (inclusive) with myopia Best corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye Difference in spherical equivalent power between the two eyes (anisometropia based on manifest refraction) must be less than or equal to 0.75 D Exclusion Criteria: Current use of any myopia control treatment such as atropine, multifocal contact lenses, or orthokeratology (NOTE: Prior bilateral usage acceptable as long as treatment stopped at least 6 months before screening visit. Any subject with a history of unilateral myopia control treatment is excluded.) Any ocular or systemic conditions that could influence refractive development or status [e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down's syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 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: DOT Spectacle Lenses using Manufacturing Method A<br>Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A | Device: SightGlass Vision DOT Spectacle Lenses<br>* Subjects randomized to test vs control, left eyes and right eyes<br>* Other names: SightGlass Vision;|
| Experimental: DOT Spectacle Lenses using Manufacturing Method B<br>Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B | Device: SightGlass Vision DOT Spectacle Lenses<br>* Subjects randomized to test vs control, left eyes and right eyes<br>* Other names: SightGlass Vision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Axial Length Progression From Baseline | Change in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia. | 6 months | 

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