MyopiaNCT06110520
Violet Light for the Suppression of Myopia
A study testing Violet Light Lamp and White Light Lamp in people with Myopia and Phototherapy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The study explores the suppression of myopia via violet light. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Phototherapy
- What is being tested?
- Violet Light Lamp and White Light Lamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2023to 6 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45209
About this study
Official title: Violet Light for Treatment of Myopia
The study explores the suppression of myopia via violet light.
Read the 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.
- Conditions
- Myopia, Phototherapy
- Being tested
- Violet Light Lamp, White Light Lamp
- Keywords
- Myopia, Violet Light
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Violet Light LampDevice
Medical grade lamps with Violet LEDs enabled
White Light LampDevice
Standard bedside lamp with standard 4000K LED light bulb.
| Study group | Role | What they receive |
|---|---|---|
| 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 +). Receives: 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 -). Receives: 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 +). Receives: Device: White Light Lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Length
Measurement of the distance between anterior cornea and retina via IOL Master in millimeters.
Measured: Measured at baseline, and 12 months.
Refractive Error
The measurement of power eye measured in diopters.
Measured: 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: Measured at baseline, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start7 Jun 2023
- Primary completion6 Jul 2026
- Study completion6 Jul 2026
Why it stopped: Recruitment issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110520
- Sponsor's protocol ID
- 2021-0289
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Violet Light for Treatment of Myopia
- ClinicalTrials.gov ID
- NCT06110520
- Acronym / sponsor ID
- 2021-0289
- Conditions
- Myopia, Phototherapy
- Keywords
- Myopia, Violet Light
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Violet + / Lens + | Experimental | Device: Violet Light LampSubjects 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 +). |
| Violet + / Lens - | Experimental | Device: Violet Light LampSubjects 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 + | Placebo comparator | Device: White Light LampSubjects 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 +). |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children must be between 5 to <13 years old.
- Diagnosis of Myopia (ICD-10-CM Diagnosis
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Violet Light LampMedical grade lamps with Violet LEDs enabled | Device | Violet + / Lens +, Violet + / Lens - |
| White Light LampStandard bedside lamp with standard 4000K LED light bulb. | Device | Violet - / Lens + |
Primary outcome
Axial Length
Time frame: Measured at baseline, and 12 months.
Measurement of the distance between anterior cornea and retina via IOL Master in millimeters.
Refractive Error
Time frame: Measured at baseline, and 12 months.
The measurement of power eye measured in diopters.
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.
Results and safety
The study was stopped early (reason given: Recruitment issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Violet Light Lamp and White Light Lamp in people with Myopia and Phototherapy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment issues.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial Length (time frame: Measured at baseline, and 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.