The EYERISING Study
Repeated Low-level Red Light for Myopia Progression Study: An International, Multicenter, Multiethnic, Randomized Controlled Trial, IPOSC Study
The purpose of this clinical trial is to see if and how well Repeated Low-Level Red Light (RLRL) therapy works to control myopia over 12 months. The main question it aims to answer is:
- Can RLRL therapy help slow down the worsening of myopia?
Participants will use a red-light therapy investigational device at home, 5 days a week for 12 months.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Angie Adler
- 电话号码：608-265-7557
- 邮箱：amadler1@wisc.edu
学习地点
-
-
Bagmati Province
-
Kathmandu、Bagmati Province、尼泊尔
- Tilganga Institute of Ophthalmology
-
接触：
- Srijana Adhikari
- 邮箱：srij_a@yahoo.com
-
首席研究员：
- Srijana Adhikari
-
-
-
-
Wisconsin
-
Madison、Wisconsin、美国、53715
- University of Wisconsin - Madison
-
接触：
- Angie Adler
- 电话号码：608-265-7557
- 邮箱：amadler1@wisc.edu
-
首席研究员：
- Yasmin Bradfield, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 6 and ≤ 12 (at screening)
- Myopia: Cycloplegic SER -1.0 to -7.0 D
- Astigmatism: < 1.5 D
- Anisometropia: < 1.5 D
- Informed parental consent
- Consistent access to wireless internet
Exclusion Criteria:
-
A subject who is born female and who is currently menstruating or has begun menstruation (menarche).
- Ophthalmic diseases, conditions, or syndromes other than refractive errors
- Previous use of treatment for myopia control (e.g., defocusing lenses or contact lenses, orthokeratology, atropine, and pirenzepine)
- Any previous ocular surgery
- Systemic diseases (e.g., endocrine, cardiac diseases) and developmental anomalies
- Inability to attend regular follow up visits
- Participants with any symptom, disease, or other condition that, in the opinion of the investigators, may affect the effectiveness of the investigational treatment and/or the ability of the participant to complete study activities
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Red light therapy
Participants will receive red light therapy |
RLRL device emits low-level red-light with a wavelength of 650 ± 10 nm. The device provides light at a power of 2.00 ± 0.50 mW. |
|
安慰剂比较：Placebo
Participants will receive placebo therapy |
Placebo device will match the RLRL in appearance but will not emit light. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in cycloplegic spherical equivalent refraction (SER)
大体时间：Baseline, 4 months, 8 months, 12 months
|
SER will be measured using an autorefractometer after eye drops are given to temporarily relax the eye's focusing muscles. SER, measured in diopters (D), represents the amount of nearsightedness and will be used to measure the change in myopia from baseline. |
Baseline, 4 months, 8 months, 12 months
|
|
Change in axial length (AL)
大体时间：Baseline, 4 months, 8 months, 12 months
|
AL will be measured using the IOLMaster and reported in millimeters (mm). Change in AL from baseline will be used to assess ocular growth/myopia progression. |
Baseline, 4 months, 8 months, 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in rate of SER increase
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in rate of AL increase
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Best corrected visual acuity (BCVA)
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) composite score
大体时间：Baseline, 4 months, 8 months, 12 months
|
The NEI VFQ-25 is a 25-item questionnaire assessing vision-related functioning and quality of life. The composite score ranges from 0 to 100, with higher scores indicating better visual functioning and vision-related quality of life. |
Baseline, 4 months, 8 months, 12 months
|
|
Change in anterior chamber depth (ACD)
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in corneal curvature (CC)
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in choroidal thickness (CT)
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in White-to-White (WTW)
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Change in choroidal structures
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Intraocular pressure (IOP)
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Ocular and systemic symptoms
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
|
|
Ocular signs assessed by slit-lamp biomicroscopy and binocular indirect ophthalmoscopy
大体时间：Baseline, 4 months, 8 months, 12 months
|
Baseline, 4 months, 8 months, 12 months
|
合作者和调查者
调查人员
- 首席研究员：Yasmin Bradfield, MD、University of Wisconsin, Madison
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.