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临床试验/NCT06266910
NCT06266910尚未招募不适用

Exploring the Effects of Autostereoscopic 3D Visual Training on Binocular Vision Function of Myopes Based on EEG and fNIRS

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Vergence facility

研究概览

简要总结

This study intends to conduct a relatively comprehensive binocular visual function examination and follow-up on two groups of myopic subjects, one receiving autostereoscopic 3D vision training and the other receiving 2D vision training as a control. The aim is to explore the impact of autostereoscopic 3D vision training on the accommodation and convergence functions of myopes. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in binocular visual function are accompanied by corresponding alterations in brain function.

详细描述

The prevalence of myopia is increasing, posing a serious threat to our visual health. East Asia and Southeast Asia are high-prevalence areas for myopia, with over 80% of young people suffering from myopia. China has one of the highest rates of myopia globally. Preventing myopia occurrence and controlling its progression have become urgent public health issues.

Accommodative function may play an important role in the development of myopia. Studies indicate that factors such as hyperopic defocus caused by accommodation lag, prolonged near-plane fixation, and decreased accommodative flexibility may be associated with the occurrence and development of myopia. Convergence function works synergistically with accommodative function, and its impact on myopia is gradually gaining attention. Scientific and effective training methods to improve both accommodation and convergence functions might help slow down the progression of myopia.

Research by Huang et al. suggests that visual training based on autostereoscopic 3D display technology can improve accommodative lag and enhance accommodative flexibility. However, this study only explored the immediate effects of a single training session, and the long-term effects remain unknown. Furthermore, questions about how training induces changes in the convergence function, whether changes in accommodative function coincide with changes in the convergence function, etc., still need further investigation.

Therefore, this study intends to conduct a relatively comprehensive binocular visual function examination and follow-up on two groups of myopic subjects, one receiving autostereoscopic 3D vision training and the other receiving 2D vision training as a control. The aim is to explore the impact of autostereoscopic 3D vision training on the accommodation and convergence functions of myopes. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in binocular visual function are accompanied by corresponding alterations in brain function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

By employing a single simulation technology for blinding, both the 2D group and the 3D group share identical training equipment and a consistent video background. The only distinction lies in the subtle variation in the configuration of training markers. It is difficult for participants to differentiate their respective groups.

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • History of ophthalmic disease other than refractive error, such as strabismus, cataracts, glaucoma, retinal or optic nerve diseases
  • Use of any medications affecting accommodative function or wearing orthokeratology lenses in the past 1 month
  • History of ocular trauma or surgery
  • Suffering from systemic or mental illnesses.

研究组 & 干预措施

Three-dimensional (3D) viewing group

Experimental

Participants in this group watch a 10-minute training video displayed in 3D mode, twice a day (totaling 20 minutes), five days a week, for four consecutive weeks.

干预措施: Visual training video (Other)

Two-dimensional (2D) viewing group

Placebo Comparator

Participants in this group watched a 10-minute training video displayed in 2D mode, twice a day (totaling 20 minutes), five days a week, for four consecutive weeks.

干预措施: Visual training video (Other)

结局指标

主要结局

Vergence facility

时间窗: 8 weeks after intervention

Vergence facility was tested using a lens flipper (3△BI/12△BO lens combination) at baseline and 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after intervention.

Accommodative facility

时间窗: 8 weeks after intervention

Accommodative facility was tested using a lens flipper (+2.00D/-2.00 D lens combination) at baseline and 1 day, 1 week, 2 weeks, 4 weeks, and 8 weeks after intervention.

次要结局

  • Near point of convergence(8 weeks after intervention)
  • Electroencephalogram (EEG) node efficiency(8 weeks after intervention)
  • Accommodative response(8 weeks after intervention)
  • negative and positive relative accommodation(8 weeks after intervention)
  • Accommodation amplitude(8 weeks after intervention)
  • Negative and positive fusional vergence(8 weeks after intervention)
  • Functional near-infrared spectroscopy (fNIRS)(8 weeks after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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