Violet Light for the Suppression of Myopia

Study Overview
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Brief Summary
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The study explores the suppression of myopia via violet light.

Detailed Description
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The study uses violet light-emitting lamps as the variable and regular, white light lamps as the control in assessing whether violet light, especially during over periods of dawn and dusk could help suppress the progression of myopia in developing children.

Official Title
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Violet Light for Treatment of Myopia

Conditions
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Myopia, Phototherapy

Intervention / Treatment
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* Device: BIOS Skyview Lamp
* Device: Aooshine Bedside Lamp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children must be between 5 to <13 years old. Diagnosis of Myopia (ICD-10-CM Diagnosis Code H52.13) with refractive error: Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes Astigmatism <=1.50D in both eyes Anisometropia <=1.00D SE • Relocation outside of the CCHMC area within the next 12 months is not anticipated. Exclusion Criteria: Current or previous myopia treatment with atropine, pirenzepine, or other antimuscarinic agents Current or previous use of bifocals, progressive addition lenses, or multi-focal contact lenses Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression Current or prior history of manifest strabismus, amblyopia, or nystagmus Abnormality of cornea, lens, central retina, iris, or ciliary body Prior eyelid, strabismus, intraocular, or refractive surgery Down syndrome or cerebral palsy

Ages Eligible for Study
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Minimum Age: 5 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three single groups: Violet + / Lens + Lamp emits violet light and subjects are either wearing no refractive correction or wearing CR-39 lenses that completely transmit violet light. Violet + / Lens - Lamp emits violet light and subjects are wearing violet-filtering glasses that block out violet light from reaching their eyes. Violet - / Lens - Lamp does not violet light and subjects are wearing CR-39 lenses that completely transmit violet light.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Violet + / Lens +<br>Subjects use a violet light emitting lamp (device intervention - minimally invasive as it's simply a source of light) with CR-39 lenses for their refractive correction. The lamp introduces violet light (Violet +) and the CR-39 lenses allow for the transmission of violet light through the lenses (Lens +). | Device: BIOS Skyview Lamp<br>* Medical grade lamps with Violet LEDs enabled<br>|
| Experimental: Violet + / Lens -<br>Subjects use a violet light emitting lamp (device intervention - minimally invasive as it's simply a source of light) with polycarbonate lenses for their refractive correction. The lamp introduces violet light (Violet +) while the polycarbonate lenses block the transmission of violet light through the lenses (Lens -). | Device: BIOS Skyview Lamp<br>* Medical grade lamps with Violet LEDs enabled<br>|
| Placebo Comparator: Violet - / Lens +<br>Subjects use a lamp with NO violet light (Violet -) with CR-39 lenses for their refractive correction. CR-39 lenses allow for the transmission of violet light through the lenses (Lens +). | Device: Aooshine Bedside Lamp<br>* Standard bedside lamp with standard 4000K LED light bulb.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial Length | Measurement of the distance between anterior cornea and retina via IOL Master in millimeters. | Measured at baseline, and 12 months. | 
| Refractive Error | The measurement of power eye measured in diopters. | Measured at baseline, and 12 months. | 
| Visual Acuity | The measurement of how well a person can see letters at a specific distance, measured in logMAR. | Measured at baseline, and 12 months. | 

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