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 volunteersQualifiers
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
DeviceMedical grade lamps with Violet LEDs enabled
White Light Lamp
DeviceStandard bedside lamp with standard 4000K LED light bulb.
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup 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.Sponsors and contacts
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Source ClinicalTrials.gov