Violet Light for the Suppression of Myopia

January 9, 2024 updated by: Children's Hospital Medical Center, Cincinnati

Violet Light for Treatment of Myopia

The study explores the suppression of myopia via violet light.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45209
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Melissa Rice, OD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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: Violet Light 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: Violet Light 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: White Light Lamp
Standard bedside lamp with standard 4000K LED light bulb.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myopia

Clinical Trials on Violet Light Lamp

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe