Violet Light for the Suppression of Myopia

Children's Hospital Medical Center, Cincinnati65 enrolled

Overview

The study explores the suppression of myopia via violet light.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Myopia Phototherapy

Interventions

Violet Light LampDEVICE

Medical grade lamps with Violet LEDs enabled

White Light LampDEVICE

Standard bedside lamp with standard 4000K LED light bulb.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Axial Length

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

Time frame: Measured at baseline, and 12 months.

Refractive Error

The measurement of power eye measured in diopters.

Time frame: 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.

Time frame: Measured at baseline, and 12 months.

Data from ClinicalTrials.gov

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