Development of Digital Defocus Vision Training (DDVT) System Based on Virtual Reality Technology and Its Application in Myopia Regulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 3
- 主要终点
- the axial length (AL)
研究概览
简要总结
Myopia is the first major disease affecting the visual health of young children. With the increase in the use of electronic products and the decrease in the time for outdoor exercise, the incidence of myopia is increasing year by year. Smith et al. firstly found that peripheral retinal defocus affects the course of myopia development in rhesus monkeys. Subsequent studies have shown that peripheral retinal hyperopic defocus can lead to the growth of the axial length (AL), leading to the development of myopia, while peripheral retinal myopic defocus can effectively slow down the growth of the AL, thus delaying the progression of myopia. Defocus signals can simultaneously change the thickness of the choroid, the vascular tissue behind the retina, and the pigment epithelium, and change the thickness and hardness of the sclera, inhibiting or promoting the growth of the axial length. Therefore, many methods have been designed to intervene in the development of myopia, including orthokeratology and peripheral defocusing glasses. The maintenance process of orthokeratology lens is complex and there is a risk of infection. Peripheral defocus glasses need to be worn for a long time, and the visual quality is unstable. It is still necessary to explore safer, more effective and more practical methods for myopia control. In addition, there may be some correlation between the development of myopia and the decrease of choroidal blood flow. Defocus signal may promote the increase of choroidal blood flow, which may be a way to prevent and control myopia.
Therefore, the investigators integrated the digital defocus paradigm into VR devices and developed a digital defocus vision training (DDVT) system. The purpose of this study was to investigate the effectiveness and safety of DDVT in the prevention and control of myopia in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children aged 6 to 12 years
- •diagnosis of myopia with SER of -0.75 to -6.00 D
- •regular astigmatism, and astigmatism less than 2.50D
- •anisometropia less than 1.50 D
- •a logMAR best-corrected visual acuity (BCVA) of 0.00 or better
- •an understanding by participants and their legal guardians of the purpose of the study
排除标准
- •other myopia control therapies in the last 6 months (including but not limited to atropine and orthokeratology)
- •strabismus, amblyopia, congenital lens dislocation, congenital cataract, glaucoma, uveitis, nystagmus, keratoconus, eye neoplasms and other ocular diseases
- •systemic diseases such as nephrotic syndrome or diabetes
- •structural changes in the eyeball, a history of ocular surgery or trauma
- •other systemic diseases affecting eye health
- •participants in other clinical trials at the same time.
研究组 & 干预措施
DDVT training group
During a six-month follow-up period, participants received 10 minutes of DDVT twice a day (once in the morning, and the other in the afternoon) using a head-mounted virtual reality (VR) display. In daily life during non-training sessions, participants were required to wear frame glasses with complete correction.
干预措施: Development of digital defocus vision training (DDVT) (Device)
control group
The control group did not have any myopia prevention and control intervention in half a year, and only wore complete-corrected frame glasses in daily life
结局指标
主要结局
the axial length (AL)
时间窗: 1 year
The axial length of the eye is the distance from the anterior surface of the cornea to the posterior surface of the retina. In a normal adult, it is approximately 24 mm , and its growth is closely related to myopia . AL was measured using the IOL Master (Carl Zeiss 500, Meditec, Oberkochen, Germany)
次要结局
- spherical equivalent refraction(1 year)
研究者
Jin Yuan
PHD
Beijing Tongren Hospital
