Clinical trial NCT06433102: Evaluation of Visual Training System in Patients With Glaucoma
Official title: Assessing the Effectiveness of Visual Perception Training Based on Lateral Masking Paradigm in Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Glaucoma
Keywords: Visual perceptual training
Vision rehabilitation
Glaucoma
Lateral masking paradigm
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Contrast sensitivity function
timeFrame: 6 months after intervention
Secondary outcomes:
measure: Visual field
timeFrame: 6 months after intervention
measure: Visual acuity
timeFrame: 6 months after intervention
measure: Stereoacuity
timeFrame: 6 months after intervention
measure: Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40)
timeFrame: 6 months after intervention
measure: National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25)
timeFrame: 6 months after intervention
measure: Reach-and-Grasp Kinematics
timeFrame: 6 months after intervention
measure: Electroencephalogram (EEG) node efficiency
timeFrame: 6 months after intervention
measure: Functional near-infrared spectroscopy (fNIRS)
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Opthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Foster PJ, Johnson GJ. Glaucoma in China: how big is the problem? Br J Ophthalmol. 2001 Nov;85(11):1277-82. doi: 10.1136/bjo.85.11.1277.
citation: Fontenot JL, Bona MD, Kaleem MA, McLaughlin WM Jr, Morse AR, Schwartz TL, Shepherd JD, Jackson ML; American Academy of Ophthalmology Preferred Practice Pattern Vision Rehabilitation Committee. Vision Rehabilitation Preferred Practice Pattern(R). Ophthalmology. 2018 Jan;125(1):P228-P278. doi: 10.1016/j.ophtha.2017.09.030. Epub 2017 Nov 4. No abstract available.
citation: Matteo BM, Vigano B, Cerri CG, Perin C. Visual field restorative rehabilitation after brain injury. J Vis. 2016 Jul 1;16(9):11. doi: 10.1167/16.9.11.
citation: Polat U, Ma-Naim T, Belkin M, Sagi D. Improving vision in adult amblyopia by perceptual learning. Proc Natl Acad Sci U S A. 2004 Apr 27;101(17):6692-7. doi: 10.1073/pnas.0401200101. Epub 2004 Apr 19.
citation: Zhong J, Wang W, Li J, Wang Y, Hu X, Feng L, Ye Q, Luo Y, Zhu Z, Li J, Yuan J. Effects of Perceptual Learning on Deprivation Amblyopia in Children with Limbal Dermoid: A Randomized Controlled Trial. J Clin Med. 2022 Mar 28;11(7):1879. doi: 10.3390/jcm11071879.