Repeated Low-level Red-light Therapy in High Myopia Children and Teenagers: a Prospective Single-arm Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence rate of axial length shortening greater than 0.05 mm
研究概览
简要总结
The purpose of this clinical trial is to investigate the incidence and magnitude of axial length shortening after repeated low-level red-light therapy in high myopia children and teenagers.
详细描述
High myopia has become a major public concern globally, which is characterized by excessive axial elongation of the eyeball. Axial elongation is accompanied by mechanical stretching and thinning of the choroid and sclera, causing vision-threatening complications. Repeated low-level red-light (RLRL) therapy is an emerging effective and safe therapy for myopia control. Previous clinical trials in China have observed clinically significant axial shortening after RLRL treatment.
The purpose of this study is to investigate and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in highly myopic children and teenagers aged 8-18 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents/guardians according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, slit lamp, fundus camera and optical coherence tomography/angiography will be measured at 1-, 3-, 6- and 12-month follow-up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of consent.
- •Age: ≥ 8 and ≤ 18 years at enrolment.
- •High myopia: cycloplegic sphere of -6.00 diopters (D) or greater in both eyes.
- •Willing and able to participate in all required activities of the study.
- •The children currently on myopia control treatment can be recruited if myopia control treatments (including but not limited to atropine, orthokeratology, rigid gas-permeable lenses, defocus spectacles, etc.) are discontinued for at least 2 weeks.
- •Normal fundus, tessellated fundus or with peripapillary diffuse chorioretinal atrophy.
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.
- •Pathologic myopia with signs of macula-involving diffuse chorioretinal atrophy, patchy chorioretinal atrophy, macular atrophy, lacquer cracks, myopic choroidal neovascularization or Fuchs' spots.
- •Strabismus and binocular vision abnormalities in either eye.
- •Previous any intraocular surgery affecting refractive status.
- •Other reasons, 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
Incidence rate of axial length shortening greater than 0.05 mm
时间窗: 12 months
Incidence rate of axial length shortening \> 0.05 mm is characterized as the ratio of the number of participants whose axial length has shortened by greater than 0.05 mm to the total number of participants. Axial length (mm) is measured using the IOL Master.
次要结局
- Changes in choroidal thickness (μm)(1, 3, 6 and 12 months)
- Incidence of self-reported adverse events(1, 3, 6 and 12 months)
- Incidence rates of axial length reduction greater than 0.10 mm and 0.20 mm(12 months)
- Changes in corneal curvature (mm)(1, 3, 6 and 12 months)
- Change of pathologic myopia fundus META-PM grading(1, 3, 6 and 12 months)
- Change in best corrected visual acuity(1, 3, 6 and 12 months)
- Magnitude of axial length shortening among shortened eyes(12 months)
- Changes in axial length (mm)(1, 3, 6 and 12 months)
- Changes in anterior chamber depth (mm)(1, 3, 6 and 12 months)
- Changes in white to white (mm)(1, 3, 6 and 12 months)
- Change of cycloplegic spherical equivalent refraction(1, 3, 6 and 12 months)