Evaluation of Visual Training System in Patients With Glaucoma

Sun Yat-sen University

Status: Invitation-only

Conditions: Glaucoma

Treatments: Other: Visual perceptual training based on the lateral masking paradigm

Study type: Interventional

Funder types: Other

Identifiers

NCT06433102

2023KYPJ008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. age ≥ 10 years old
2. diagnosed with primary glaucoma or developmental glaucoma
3. the best corrected visual acuity ≥0.1 and the mean deviation of the visual field worse or equal to -6 dB
4. visual acuity, intraocular pressure, and other eye conditions have been stable for more than 3 months
5. participants capable of understanding the purpose of the study and providing informed consent
6. participants capable of cooperating with relevant examinations.

Exclusion criteria

1. a history of eye surgery or eye laser within three months
2. 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.
3. serious systemic diseases, such as neurological diseases, cardiovascular diseases, psychological diseases, malignant tumors, etc
4. pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

the training group

Experimental group

Description:

Participants in this group received visual perceptual training based on the lateral masking paradigm every other day for 35 to 45 minutes, with each cycle consisting of 40 sessions, lasting approximately 3 months. The training began in the hospital during the first week and continued at home using personal computers thereafter. The personal computers were connected to a central server via the internet.

Treatment:

Other: Visual perceptual training based on the lateral masking paradigm

the control group

No Intervention group

Description:

The control group maintained the original treatment plan without any additional interventions.