Assessing the Effectiveness of Visual Perception Training Based on Lateral Masking Paradigm in Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Contrast sensitivity function
研究概览
简要总结
This study intends to conduct visual function examinations and follow-ups on two groups of glaucoma patients, one receiving visual perceptual training and the other serving as a control without training. The aim of this study is to explore the effects of visual perceptual training based on the lateral masking paradigm on patients' visual function. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in patients' visual function are accompanied by corresponding alterations in brain function.
详细描述
Glaucoma is a chronic eye disease that causes irreversible damage to the optic nerve and can lead to severe vision loss and blindness. In China, the blindness rate among glaucoma patients is 22.7%, accounting for 8.8% of the total blind population. Among individuals aged 40 and above in urban and rural areas of China, approximately 9.2 million suffer from glaucoma, with 55% experiencing blindness in at least one eye and 18.1% experiencing blindness in both eyes [1,2]. Glaucoma patients may experience severe impairment in visual function, leading to significant limitations in vision-related activities such as mobility and visual searching. This has a negative impact on the quality of life (QOL) of patients, increasing the burden on individuals, families, and society.
Vision Rehabilitation (VR) is an integral component of the eye care continuum, spanning from diagnosis to treatment and rehabilitation [3]. It aims to assist visually impaired patients in maximizing their remaining vision, facilitating easier performance of daily activities, promoting independence, and enhancing quality of life (QOL). However, for glaucoma patients with visual field defects, traditional methods such as inverted telescopes and prism glasses are plagued by shortcomings such as unattractive appearance, bulkiness, blurred visual quality, and challenges in adaptation.
Perceptual Learning (PL) is a novel rehabilitation approach aimed at enhancing visual performance through intensified practice of visual tasks. Many studies have shown that visual perceptual training can improve visual function in patients with different types of amblyopia or presbyopia, as the nervous system exhibits significant neuroplasticity [4-6]. However, there is limited research on visual perceptual training in visual rehabilitation for glaucoma.
Therefore, this study intends to conduct visual function examinations and follow-ups on two groups of glaucoma patients, one receiving visual perceptual training and the other serving as a control without training. The aim of this study is to explore the effects of visual perceptual training based on the lateral masking paradigm on patients' visual function. Additionally, synchronized EEG-fNIRS signals will be collected to investigate whether changes in patients' 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
- Single (Outcomes Assessor)
盲法说明
The technical staff and research assistants involved in subject enrollment, outcome measurement, and data collection are blinded to the intervention allocation.
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 10 years old
- •diagnosed with primary glaucoma or developmental glaucoma
- •the best corrected visual acuity ≥0.1 and the mean deviation of the visual field worse or equal to -6 dB
- •visual acuity, intraocular pressure, and other eye conditions have been stable for more than 3 months
- •participants capable of understanding the purpose of the study and providing informed consent
- •participants capable of cooperating with relevant examinations.
排除标准
- •a history of eye surgery or eye laser within three months
- •complicated with other ophthalmopathy affecting visual function (except cataract, ametropia), such as age-related macular degeneration, diabetic retinopathy, optic nerve disease, retinal vascular disease, etc.
- •serious systemic diseases, such as neurological diseases, cardiovascular diseases, psychological diseases, malignant tumors, etc
- •pregnant or lactating women.
结局指标
主要结局
Contrast sensitivity function
时间窗: 6 months after intervention
Contrast sensitivity function (CSF) was assessed using the qCSF method at baseline, and at 1 day, 3 months, and 6 months after the intervention. The qCSF method employed a Bayesian adaptive learning procedure. Data collected for analysis included contrast sensitivity at 19 spatial frequencies, the area under the log CSF (AULCSF), and the cutoff spatial frequency.
次要结局
- Visual field(6 months after intervention)
- Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40)(6 months after intervention)
- Electroencephalogram (EEG) node efficiency(6 months after intervention)
- Visual acuity(6 months after intervention)
- Stereoacuity(6 months after intervention)
- Reach-and-Grasp Kinematics(6 months after intervention)
- Functional near-infrared spectroscopy (fNIRS)(6 months after intervention)
- National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25)(6 months after intervention)