Effects of Various Stimulus Characteristics on Myopic Progression Using Kubota Glass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Axial length
研究概览
简要总结
Length of the eye will be measured in subjects exposed to various stimulus characteristics using an electronic spectacle which presents illuminated targets to the eye. The results will be analyzed to determine which stimulus characteristics may be most beneficial for use in the device.
详细描述
Axial length measurements will be taken before and after two-hour monocular exposure to various stimulus characteristics using an electronic spectacle which presents illuminated defocus targets to the retina. Areas of investigation include the dioptric amount of defocus, the intensity of illumination, the spectrum of illumination, and the shape of the illumination target. The transient axial length results will be analyzed to determine which stimulus characteristics may be most beneficial for slowing myopic eye growth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
- •Sign written Informed Consent (and the California Bill of Rights, if applicable).
- •Ages 8-24 (inclusive) and able to understand and assent to participation
- •Have need of optical correction for myopia, from -1.00 to -5.00 diopters (D).
- •Have a refractive astigmatism of less than -1.00 D.
- •Best Spectacle Corrected Visual Acuity (BSCVA) of 20/25 or better.
- •Be willing and able to follow instructions and attend the schedule of follow-up visits.
排除标准
- •Not able or willing to provide informed consent and assent
- •Eye injury or surgery within twelve weeks immediately prior to enrollment
- •Currently enrolled in an ophthalmic clinical trial
- •Pregnant or lactating or expect to become pregnant during the trial
- •Evidence of systemic or ocular abnormality, infection or disease
- •Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye
- •Habitually uncorrected anisometropia ≥ 2.00
- •Subjects who have undergone corneal refractive surgery
- •Use of a treatment for myopia progression within the past 6 months, including atropine, specialized spectacle lenses, orthokeratology, specialized soft contact lenses
结局指标
主要结局
Axial length
时间窗: 2 hours
Change in axial length as measured by optical biometry after the use of Kubota Glass
次要结局
未报告次要终点