Violet Light for the Suppression of Myopia

NCT06110520 | Recruiting

• 1 other identifier: 2021-0289
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The study explores the suppression of myopia via violet light.

Conditions

Myopia; Phototherapy

Keywords

Myopia; Violet Light

Outcome Measures

Primary Outcomes (3)

• Axial Length

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

  Measured at baseline, and 12 months.

• Refractive Error

  The measurement of power eye measured in diopters.

  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.

  Measured at baseline, and 12 months.

Study Arms (3)

Violet + / Lens +

EXPERIMENTAL

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 +).

Device: Violet Light Lamp

Violet + / Lens -

EXPERIMENTAL

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 -).

Device: Violet Light Lamp

Violet - / Lens +

PLACEBO COMPARATOR

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 +).

Device: White Light Lamp

Interventions

Violet Light Lamp DEVICE

Medical grade lamps with Violet LEDs enabled

Violet + / Lens +; Violet + / Lens -

White Light Lamp DEVICE

Standard bedside lamp with standard 4000K LED light bulb.

Violet - / Lens +

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children must be between 5 to \<13 years old.
• Diagnosis of Myopia (ICD-10-CM Diagnosis
• Code H52.13) with refractive error:
• Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
• Astigmatism \<=1.50D in both eyes
• Anisometropia \<=1.00D SE • Relocation outside of the CCHMC area within the next 12 months is not anticipated.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45209, United States

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Jillian Bulman, MPH

CONTACT

9374034996; jillian.bulman@cchmc.org

Melissa Rice, OD

CONTACT

513-636-4751; Melissa.rice@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: October 31, 2023
• Study Start: June 7, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)