Evaluation of Visual Training System in Patients With Glaucoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-03

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The technical staff and research assistants involved in subject enrollment, outcome measurement, and data collection are blinded to the intervention allocation.

Study Groups

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the training group

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.

Group Type EXPERIMENTAL

Visual perceptual training based on the lateral masking paradigm

Intervention Type OTHER

Visual perceptual training is a novel rehabilitation approach aimed at enhancing visual performance through practice of visual tasks. Patients received visual perceptual training based on the lateral masking paradigm every other day. Each training session consisted of 9 stages, totaling 900 trials, lasting 35 to 45 minutes. The stimuli consisted of a central Gabor patch with relatively low contrast positioned in the central fixation area, along with co-linear high-contrast Gabor patches distributed above and below the central stimulus. These stimuli were presented on a Liquid Crystal Display (LCD) monitor, with a training distance of 150 cm.

the control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Visual perceptual training based on the lateral masking paradigm

Visual perceptual training is a novel rehabilitation approach aimed at enhancing visual performance through practice of visual tasks. Patients received visual perceptual training based on the lateral masking paradigm every other day. Each training session consisted of 9 stages, totaling 900 trials, lasting 35 to 45 minutes. The stimuli consisted of a central Gabor patch with relatively low contrast positioned in the central fixation area, along with co-linear high-contrast Gabor patches distributed above and below the central stimulus. These stimuli were presented on a Liquid Crystal Display (LCD) monitor, with a training distance of 150 cm.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes