Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2023-06-07
2028-01-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
TRIPLE
Study Groups
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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 +).
Violet Light Lamp
Medical grade lamps with Violet LEDs enabled
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 -).
Violet Light Lamp
Medical grade lamps with Violet LEDs enabled
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 +).
White Light Lamp
Standard bedside lamp with standard 4000K LED light bulb.
Interventions
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Violet Light Lamp
Medical grade lamps with Violet LEDs enabled
White Light Lamp
Standard bedside lamp with standard 4000K LED light bulb.
Eligibility Criteria
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Inclusion Criteria
* 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 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
5 Years
12 Years
ALL
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Jillian Eltzroth, MPH
Role: primary
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2021-0289
Identifier Type: -
Identifier Source: org_study_id