Effect of Repeated Low-level Red-light (RLRL) Therapy on the Choroid and the Retina in Diabetes and Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 58
- 主要终点
- Changes in subfoveal choroidal thickness
研究概览
简要总结
The choroidal thickness was found to be thinner in diabetic eyes without retinopathy compared to healthy eyes, thus choroidal thickness might be an important parameter for the development of diabetic retinopathy in diabetic eyes without retinopathy. 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. This study aims to answer whether RLRL therapy can thicken choroidal thickness in adults with diabetes mellitus or diabetic retinopathy.
详细描述
The goal of this study is to investigate the effect of repeated low-level red-light (RLRL) therapy on the choroidal and retinal structures in diabetes mellitus and diabetic retinopathy. This study will be conducted with a prospective randomized cross-over design with a total follow-up of 3 months. The control group will use the sham device but with only 5% of the original device's power. Comprehensive ophthalmic examinations, including visual acuity, intraocular pressure, optical coherence tomography, optical coherence tomography angiography, slit lamp will be assesses at baseline and within the follow up
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
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 35-55 years
- •Diagnosis of type 2 diabetes mellitus
- •No DR or only mild non-proliferative DR (NPDR) assessed by baseline clinical ocular signs and 7-field fundus color photography
排除标准
- •Spherical equivalent (SE) ≤ -6.0 diopter or axial length ≥26 mm
- •Patients with complications such as DME and retinal detachment
- •History of ocular surgical operations
- •Severe systemic diseases
- •Those who could not cooperate with the examination for any reason
- •Cognitive impairment or mental illness
- •Patients with other ocular diseases
结局指标
主要结局
Changes in subfoveal choroidal thickness
时间窗: 1 month
Changes in subfoveal choroidal thickness after 1-month RLRL treatment, which is measured by optical coherence tomography.
次要结局
- Changes in choroidal vascularity index(1 month)
- Changes in DR grading(1 month)
- Changes in OCTA-derived parameters of the choroid and retina(1 month)