Evaluation of Visual Training System in Patients With Glaucoma

Glaucoma Clinical Trial

Official title:

Assessing the Effectiveness of Visual Perception Training Based on Lateral Masking Paradigm in Glaucoma Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06433102
• Other study ID #: 2023KYPJ008
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: April 26, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Zhongshan Opthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast sensitivity function	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.	6 months after intervention
Secondary	Visual field	Visual field testing was conducted using automated perimetry with the 30-2 Swedish interactive threshold algorithm. The examination was performed at baseline and 1 day, 3 months, and 6 months after the intervention.	6 months after intervention
Secondary	Visual acuity	Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart was used. The examination was performed at baseline and 1 day, 3 months, and 6 months after the intervention.	6 months after intervention
Secondary	Stereoacuity	Stereoacuity was measured using the Titmus stereopsis test at baseline, as well as 1 day, 3 months, and 6 months after the intervention.	6 months after intervention
Secondary	Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40)	The GVFQ-40 consists of 40 items and measures the difficulty of daily activities of glaucoma patients in five domains of functioning (mobility, visual tracking, reading, identification and night vision ). Each item has six answer options, that is, no difficulty (score = 1), mild difficulty (score = 2), moderate difficulty (score = 3), extremely difficult (score = 4), completely unable to complete (score = 5), and do not perform for nonvisual reasons (no score). The GVFQ-40 was administered at baseline and 1 day, 3 months, and 6 months after the intervention.	6 months after intervention
Secondary	National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25)	The National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25) is a valid and reliable vision-related quality of life (QOL) questionnaire designed for persons who have chronic eye diseases or low vision. It includes 25 items that comprise 11 subscales on different aspects of vision-related functioning and QOL and 1 item on general health. NEI VFQ-25 scores range from 0 to 100, with a higher score representing better functioning. The NEI VFQ-25 was administered at baseline and 1 day, 3 months, and 6 months after the intervention.	6 months after intervention
Secondary	Reach-and-Grasp Kinematics	The reaching-and-grasping (prehension) task was conducted to assess patients' eye-hand coordination abilities at baseline and 1 day, 3 months, and 6 months post-intervention. The motion capture system recorded the movements of the preferred hand. Various metrics of prehension planning and online control were measured, including initiation time, total movement duration, peak velocity, and other relevant parameters.	6 months after intervention
Secondary	Electroencephalogram (EEG) node efficiency	Electroencephalogram was performed to track the electrical activity of the brain in real time at baseline and 1 day, 3 months, and 6 months after the intervention. Node efficiency was calculated. Node efficiency is a metric that characterizes the efficiency of a single node in connecting with all other parts of the network. It reflects the centrality and importance of a node within the network.	6 months after intervention
Secondary	Functional near-infrared spectroscopy (fNIRS)	Functional near-infrared spectroscopy (fNIRS) was conducted to capture spatial information on cerebral blood flow and oxygenation conditions at baseline, as well as 1 day, 3 months, and 6 months after the intervention.	6 months after intervention