Effect of Different Intensities of Repeated Low-Level Red-Light Therapy on Choroidal and Retinal Blood Flow Among Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes of macular choroidal thickness.
研究概览
简要总结
The purpose of this clinical trial is to evaluate the effect of different intensities of repeated low-level red-light (RLRL) therapy on the choroidal and retinal blood flow among adults.
详细描述
Repeated low-level red-light (RLRL) therapy is an emerging innovative and non-invasive treatment for a variety of eye diseases. Notably, RLRL was found to be effective in thickening choroidal thickness in a 1-year randomized controlled trial, indicating its potential in modulating blood flow in the fundus. However, it remains unclear how long it takes for the RLRL to make a difference in fundus blood flow and whether there is a dose-response.
The purpose of this study is to evaluate the different intensities of RLRL on the choroidal and retinal blood flow among adults. This study will be conducted with a randomized cross-over design with a total follow-up of 3 months. The RLRL therapy will be carried out in the study site under supervision according to a standard protocol. Ophthalmic examinations, including visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, spherical equivalent refraction, slit lamp, and biometrics will be evaluated at enrollment and during follow-ups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-40 years at enrolment.
- •Healthy adults with best corrected visual acuity equal to or better than 1.0 in both eyes.
- •No other ocular condition except for myopia.
- •Provision of consent and able to participate in all required activities of the study.
排除标准
- •Secondary myopia, such as a history of retinopathy of prematurity or neonatal problems, or syndromic myopia with a known genetic disease or connective tissue disorders, such as Stickler or Marfan syndrome.
- •Strabismus and vision abnormalities in either eye.
- •Refractive media opacity: corneal opacities, cataracts, or implanted intraocular lens, etc.
- •Ocular abnormalities that affect retinal function: macular degeneration, diabetic retinopathy, retinal detachment, glaucoma, or ocular hypertension, endophthalmitis, uveitis, optic neuropathy, etc.
- •Previous history of refractive surgery, intraocular surgery, laser therapy, and intravitreal injection, etc.
- •Systemic abnormalities: diabetes, hypertension, etc.
- •Drugs therapies with toxicity effects on the retina: hydroxychloroquine, etc.
- •Other contraindications, including but not limited to ocular or other systemic abnormalities, that the physician may consider inappropriate for enrolment.
结局指标
主要结局
Changes of macular choroidal thickness.
时间窗: 1 month
Changes in the macular choroidal thickness are characterized as the difference following 1 month with RLRL therapy relative to the baseline which is measured by optical coherence tomography.
次要结局
- Changes in OCTA-derived parameters of retina.(1 month)
- Changes in OCTA-derived parameters of choriocapillaris.(1 month)
- Incidence of treatment-emergent adverse events(1 month)