Violet Light for Treatment of Myopia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The study explores the suppression of myopia via violet light.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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 +).
干预措施: Violet Light Lamp (Device)
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 -).
干预措施: Violet Light Lamp (Device)
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 +).
干预措施: White Light Lamp (Device)
结局指标
主要结局
Visual Acuity
时间窗: Measured at baseline, and 12 months.
The measurement of how well a person can see letters at a specific distance, measured in logMAR.
Axial Length
时间窗: Measured at baseline, and 12 months.
Measurement of the distance between anterior cornea and retina via IOL Master in millimeters.
Refractive Error
时间窗: Measured at baseline, and 12 months.
The measurement of power eye measured in diopters.
次要结局
未报告次要终点