Repeated Low-Level Red-Light Therapy for Shortening Axial Length in Chinese High Myopia Children and Teenagers: a Prospective Single-Arm Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence rate (%) of axial length shortening >0.05 mm measured by the IOL Master
研究概览
简要总结
The purpose of this clinical trial is to confirm the incidence and magnitude of axial length shortening after RLRL therapy in Chinese 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. 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 confirm and identify possible mechanism for axial length (AL) shortening after 12-month RLRL therapy in Chinese highly myopic children and teenagers aged 6-16 years. In addition to single vision spectacles, subjects will receive RLRL treatment at home under supervision of the parents according to a standard protocol. Axial length, visual acuity, cycloplegic spherical equivalent refraction, intraocular pressure, slit lamp, optical coherence tomography, optical coherence tomography angiography and ultrawide-field optical coherence tomography will be measured at 1-, 3-, 6- and 12-month follow-up visits. This trial will be extended to 3 years and follow-up visits are scheduled at 18-, 24-, 30- and 36-month.
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
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of consent.
- •Age: ≥ 6 and ≤ 16 years at enrolment.
- •High myopia: cycloplegic sphere ≤ -6.00 diopters (D) 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 >0.05 mm measured by the IOL Master
时间窗: 12 months
Incidence rate of axial length shortening \> 0.05 mm is characterized as the ratio of number of participants with axial length shortening greater than 0.05 mm to the total number.
次要结局
- Incidence rates (%) of axial length shortening >0.10 mm and >0.20 mm measured by the IOL Master(12 months)
- Changes of axial length shortening (mm) among shortened eyes measured the IOL master(12 months)
- Changes in choroidal structural and perfusion parameters measured by the swept-source optical coherence tomography and optical coherence tomography angiography(1, 3, 6 and 12 months)
- Changes in retinal structures by the swept-source optical coherence tomography and optical coherence tomography angiography(1, 3, 6 and 12 months)
- Changes in axial length (mm) and other biometric parameters (mm, μm) by the IOL master(1, 3, 6 and 12 months)
- Change of cycloplegic spherical equivalent refraction (Diopter) by the autorefractor(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 (logMAR) by the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart(1, 3, 6, and 12 months)
- Incidence (%) of self-reported adverse events by the quesionnaire including but not limited to glare, flash blindness, and afterimages(1, 3, 6 and 12 months)