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Recruitment issues.
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The study explores the suppression of myopia via violet light.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 +). |
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| 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 -). |
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| 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 +). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Violet Light Lamp | Device | Medical grade lamps with Violet LEDs enabled |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Code H52.13) with refractive error:
Exclusion Criteria:
Current or previous myopia treatment with atropine, pirenzepine, or other antimuscarinic agents
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45209 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2023 | Oct 9, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Three single groups:
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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.
| White Light Lamp | Device | Standard bedside lamp with standard 4000K LED light bulb. |
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