Violet Light for the Suppression of Myopia

Cincinnati Children's Hospital Medical Center

Status: Enrolling

Conditions: Myopia; Phototherapy

Treatments: Device: White Light Lamp; Device: Violet Light Lamp

Study type: Interventional

Funder types: Other

Identifiers

NCT06110520

2021-0289

Details and patient eligibility

About

The study explores the suppression of myopia via violet light.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 3 patient groups, including a placebo group

Violet + / Lens +

Experimental group

Description:

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 +).

Treatment:

Device: Violet Light Lamp

Violet + / Lens -

Experimental group

Description:

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 -).

Treatment:

Device: Violet Light Lamp

Violet - / Lens +

Placebo Comparator group

Description:

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 +).

Treatment:

Device: White Light Lamp