Violet Light for the Suppression of Myopia

Myopia Clinical Trial

Official title:

Violet Light for Treatment of Myopia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06110520
• Other study ID #: 2021-0289
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: January 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Jillian Eltzroth, MPH
• Phone: 9374034996
• Email: jillian.eltzroth[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study explores the suppression of myopia via violet light.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: March 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia
• Phototherapy

Intervention

Device:
• Violet Light Lamp
Medical grade lamps with Violet LEDs enabled
• White Light Lamp
Standard bedside lamp with standard 4000K LED light bulb.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axial Length	Measurement of the distance between anterior cornea and retina via IOL Master in millimeters.	Measured at baseline, and 12 months.
Primary	Refractive Error	The measurement of power eye measured in diopters.	Measured at baseline, and 12 months.
Primary	Visual Acuity	The measurement of how well a person can see letters at a specific distance, measured in logMAR.	Measured at baseline, and 12 months.