The Effects of Glasses-Free 3D Training on Visual and Cognitive Function in Presbyopic Individuals
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amplitude of accommodation
研究概览
简要总结
This study aims to evaluate the effectiveness of glasses-free 3D visual training in improving visual function, visual comfort, and the application ability of visual functions in individuals with presbyopia. The research will assess changes in brain activity related to visual processing using Electroencephalogram(EEG)and Functional near-infrared spectroscopy(NIRS) before and after the training. By examining the impact of stereoscopic stimulation on the functional connectivity of brain regions, the study seeks to provide new insights into the rehabilitation of presbyopia and its underlying mechanisms. The goal is to offer a non-invasive and scientifically supported approach to improving presbyopia treatment, potentially advancing clinical practices and contributing to brain science and ophthalmology
详细描述
Presbyopia is a manifestation of aging, and the prevalence of presbyopia increases with age. About 1.7 to 2 billion people in the world have presbyopia. According to the criteria proposed by Hofstetter in 1950, presbyopia symptoms begin to appear in different individuals from the age of 40, and complete presbyopia occurs at the age of 60. With the occurrence of presbyopia, there will be a series of accompanying diseases, such as the decrease of contrast sensitivity, leading to visual discomfort. Moreover, near work is difficult and even affects daily life.
Conventional ophthalmic analysis and intervention are sufficient. Although invasive correction methods can achieve satisfactory visual quality, there is a certain surgical risk. It is necessary to consider not only the patient's general condition, but also the follow-up care. Some monocular correction at the cost of binocular stereoscopic vision will cause the damage of depth perception and seriously affect stereoscopic vision. Non-invasive methods also have certain limitations, such as glasses correction will increase the risk of falls due to the surrounding jumping and swimming effects, the effect of drugs is temporary, and will cause a series of adverse reactions. The glasses-free 3D vision training equipment is simple to operate, easy to implement the training process, and the content is variable, and no other equipment is needed. Due to the popularity of video terminals, the prevalence of electronic device related asthenopia is also increasing. In order to explore the improvement of accommodation function and the relief of asthenopia after glasses-free 3D training, a randomized controlled trial was designed. The effects of this training on the central nervous system were analyzed by electroencephalogram (EEG) and near-infrared spectroscopy (fNIRS).
The aim of this study is to evaluate the improvement of visual function, application ability of visual function, and visual comfort in patients with presbyopia through the intervention of glasses-free 3D visual training, and to evaluate the functional changes of brain visual-related areas in patients with presbyopia before and after the training combined with EEG and NIRS. To explore the effects of stereoscopic stimulation on the functional connectivity of brain regions and different frequency bands. To explore the scientific nature and effectiveness of glasses-free 3D visual training in the rehabilitation of presbyopia, to provide a new theoretical basis and method for the clinical treatment of presbyopia, and to provide more information and clues for exploring the complex stereo vision imaging mechanism in the fields of brain science and ophthalmology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The recruitment, grouping, training, and follow-up data collection of subjects were conducted by two different researchers, and the specific grouping information was announced after the end of the study. Any analysis conducted before the study was completed was only marked with simple symbols such as 1 and 2, and was marked by researchers who did not participate in data collection, sorting, and analysis.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 40-60 years old, both sexes;
- •refractive error -6.0D to 5.0D, astigmatism <2.0D, anisometropia <4.0D;
- •binocular corrected visual acuity <0.2LogMAR;
- •stereoscopic threshold ≤100 ';
- •The subjects could understand the purpose of this study and sign the informed consent.
排除标准
- •after lens replacement; People with cataracts, which affect vision, have other eye conditions such that simultaneous vision is not possible;
- •using any medication known to affect accommodative function or wearing orthokeratology lenses in the past 1 month;
- •patients with severe systemic disease or severe mental illness;
- •Other situations where the investigator considers that the subject should not participate in the study for safety reasons or the interests of the patient.
研究组 & 干预措施
Trail group
Conduct 15 minutes of naked-eye 3D vision training. Twice a day, five days a week.
干预措施: glasses-free 3D visual training (Other)
Control groups
The subjects watched ordinary 2D videos for 15 minutes each time, all under the same lighting conditions. This was done twice a day, five days a week.
结局指标
主要结局
Amplitude of accommodation
时间窗: Baseline and after 6 and 12 weeks of training
The push-up method combined with negative lens method was used. The measurements were completed by a comprehensive refractometer. It was performed according to the methods in Clinical Procedures for Ocular Examination 4th
次要结局
- Asthenopia scale(Baseline and after 6 and 12 weeks of training)
- Accommodative convergence to accommodation(AC/A)(Baseline and after 6 and 12 weeks of training)
- Hemodynamic response functions(Baseline and after 6 and 12 weeks of training)
- Functional connectivity network(Baseline and after 6 and 12 weeks of training)
- Positive relative vergence(Baseline and after 6 and 12 weeks of training)
- Vergence facility(Baseline and after 6 and 12 weeks of training)
- The node efficiency(Baseline and after 6 and 12 weeks of training)
- Convergence accommodation to convergence(CA/C)(Baseline and after 6 and 12 weeks of training)
- Negative relative vergence(Baseline and after 6 and 12 weeks of training)