Violet Light for the Suppression of Myopia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

The study explores the suppression of myopia via violet light.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children must be between 5 to <13 years old.

Diagnosis of Myopia (ICD-10-CM Diagnosis

Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes

Astigmatism <=1.50D in both eyes

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Violet Light Lamp

    Device

    Medical grade lamps with Violet LEDs enabled

  • White Light Lamp

    Device

    Standard bedside lamp with standard 4000K LED light bulb.

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: Violet + / Lens +Experimental treatment 1 intervention
Group B: Violet + / Lens -Experimental treatment 1 intervention
Group C: Violet - / Lens +Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Axial Length

Measurement of the distance between anterior cornea and retina via IOL Master in millimeters.

Time frame
Measured at baseline, and 12 months.
2

Refractive Error

The measurement of power eye measured in diopters.

Time frame
Measured at baseline, and 12 months.
3

Visual Acuity

The measurement of how well a person can see letters at a specific distance, measured in logMAR.

Time frame
Measured at baseline, and 12 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

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