Violet Light for the Suppression of Myopia

Not Applicable

Recruiting

• Conditions: Myopia; Phototherapy
• Interventions: Device: White Light Lamp; Device: Violet Light Lamp

• Registration Number: NCT06110520
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study Start: 2023-06-07
• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-10-25
• Study First Posted: 2023-10-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-11
• Primary Completion: 2025-09-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Violet - / Lens +	White Light Lamp	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 +).
Violet + / Lens -	Violet Light Lamp	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 -).
Violet + / Lens +	Violet Light Lamp	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 +).

Primary Outcome Measures

Name	Time	Method
Axial Length	Measured at baseline, and 12 months.	Measurement of the distance between anterior cornea and retina via IOL Master in millimeters.
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.
Refractive Error	Measured at baseline, and 12 months.	The measurement of power eye measured in diopters.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States