Violet Light for the Suppression of Myopia

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Recruiting

CT.gov ID

NCT06110520

Collaborator

(none)

Enrollment

Location

Arms

32.8

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study explores the suppression of myopia via violet light.

Condition or Disease	Intervention/Treatment	Phase
Myopia Phototherapy	Device: BIOS Skyview Lamp Device: Aooshine Bedside Lamp	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Three single groups: Violet + / Lens + Lamp emits violet light and subjects are either wearing no refractive correction or wearing CR-39 lenses that completely transmit violet light. Violet + / Lens - Lamp emits violet light and subjects are wearing violet-filtering glasses that block out violet light from reaching their eyes. Violet - / Lens - Lamp does not violet light and subjects are wearing CR-39 lenses that completely transmit violet light.Three single groups:Violet + / Lens + Lamp emits violet light and subjects are either wearing no refractive correction or wearing CR-39 lenses that completely transmit violet light. Violet + / Lens - Lamp emits violet light and subjects are wearing violet-filtering glasses that block out violet light from reaching their eyes. Violet - / Lens - Lamp does not violet light and subjects are wearing CR-39 lenses that completely transmit violet light.

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Violet Light for Treatment of Myopia

Actual Study Start Date :

Jun 7, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Violet + / Lens + 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: BIOS Skyview Lamp Medical grade lamps with Violet LEDs enabled
Experimental: Violet + / Lens - 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: BIOS Skyview Lamp Medical grade lamps with Violet LEDs enabled
Placebo Comparator: Violet - / Lens + 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: Aooshine Bedside Lamp Standard bedside lamp with standard 4000K LED light bulb.

Arm

Intervention/Treatment

Experimental: Violet + / Lens +

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: BIOS Skyview Lamp

Medical grade lamps with Violet LEDs enabled

Experimental: Violet + / Lens -

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: BIOS Skyview Lamp

Medical grade lamps with Violet LEDs enabled

Placebo Comparator: Violet - / Lens +

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: Aooshine Bedside Lamp

Standard bedside lamp with standard 4000K LED light bulb.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45209

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Jul 2, 2023

More Information

Publications

None provided.

Responsible Party:

Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT06110520

Other Study ID Numbers:

2021-0289

First Posted:

Oct 31, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Children's Hospital Medical Center, Cincinnati

Myopia

Violet Light

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Oct 31, 2023