Evaluation of Visual Training System in Patients With Glaucoma

NCT06433102 | Enrolling By Invitation DMC

• 1 other identifier: 2023KYPJ008
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Visual perceptual training; Vision rehabilitation; Glaucoma; Lateral masking paradigm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Visual field

  6 months after intervention

• Visual acuity

  6 months after intervention

• Stereoacuity

  6 months after intervention

• Glaucoma Visual Functioning Questionnaire-40 (GVFQ-40)

  6 months after intervention

• National Eye Institute-Visual Function Questionnaire-25 (NEI VFQ-25)

  6 months after intervention

Study Arms (2)

the training group

EXPERIMENTAL

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.

Other: Visual perceptual training based on the lateral masking paradigm

the control group

NO INTERVENTION

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

Interventions

Visual perceptual training based on the lateral masking paradigm 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 training group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Opthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (5)

• 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.

  PMID: 11673287 BACKGROUND

• 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.

  PMID: 29108747 BACKGROUND

• 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.

  PMID: 27472498 BACKGROUND

• 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.

  PMID: 15096608 BACKGROUND

• 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.

  PMID: 35407483 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The technical staff and research assistants involved in subject enrollment, outcome measurement, and data collection are blinded to the intervention allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 29, 2024
• Study Start: June 3, 2024
• Primary Completion: April 26, 2025
• Study Completion: June 30, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)