Myopia, Phototherapy
Conditions
Keywords
Myopia, Violet Light
Brief summary
The study explores the suppression of myopia via violet light.
Detailed description
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.
Interventions
DEVICEViolet Light Lamp
Medical grade lamps with Violet LEDs enabled
DEVICEWhite Light Lamp
Standard bedside lamp with standard 4000K LED light bulb.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Patients will be randomized into one of three study groups. The patient, their caregiver, and the investigator will be masked to their treatment group. The study coordinator will organize the patients study treatment and assist in any issues that arise to keep both the patient and investigator masked at all times.
Intervention model description
Three single groups: 1. Violet + / Lens + Lamp emits violet light and subjects are either wearing no refractive correction or wearing CR-39 lenses that completely transmit violet light. 2. Violet + / Lens - Lamp emits violet light and subjects are wearing violet-filtering glasses that block out violet light from reaching their eyes. 3. Violet - / Lens - Lamp does not violet light and subjects are wearing CR-39 lenses that completely transmit violet light.
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Children must be between 5 to \<13 years old. * Diagnosis of Myopia (ICD-10-CM Diagnosis Code H52.13) with refractive error: 1. Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes 2. Astigmatism \<=1.50D in both eyes 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Axial Length | Measured at baseline, and 12 months. | Measurement of the distance between anterior cornea and retina via IOL Master in millimeters. |
| Refractive Error | Measured at baseline, and 12 months. | The measurement of power eye measured in diopters. |
| Visual Acuity | Measured at baseline, and 12 months. | The measurement of how well a person can see letters at a specific distance, measured in logMAR. |
Countries
United States
Outcome results
None listed