In-person and Telehealth Visual Rehabilitation for Children With Low Vision

NCT06701617 | Recruiting

• 1 other identifier: 202306050RINC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Restorative visual rehabilitation is frequently used to enhance the visual development and function of children with low vision. An important strategy within this field is visual stimulation, which is particularly used for infants and toddlers with low vision, as well as for children who have both developmental disabilities and low vision.This study has two primary objectives.The first objective is to examine the effect of using intensive, specific, and flickering black-and-white checkerboard patterns to enhance visual function in children with mild to moderate low vision. The second objective is to develop a visual stimulation program tailored for children with severe or profound multiple disabilities and visual impairments, and to evaluate its effectiveness.

Conditions

Visual Rehabilitation; Oddball Design; Cerebral Visual Impairment; Passive Visual Stimulation; Perceptual Learning

Keywords

visual rehabilitation; visual stimulation; perceptual learning

Outcome Measures

Primary Outcomes (4)

• Visual Function Battery for Children with Special Needs

  Visual Function Battery for Children with Special Needs (VFB-CSN) is typically conducted by occupational therapists with experience in visual rehabilitation. It is a scale used to evaluate the visual function of children with special needs. It assesses eight aspects: visual reflection, eyeball asymmetry, visual acuity, contrast sensitivity, visual field, eye movements, color and shape perception, and visual attention. The scale includes 27 questions and combines standardized tests with functional assessment methods. The functional assessment method can be applied to cases that cannot cooperate with standardized tests. Children with varying degrees of visual impairment, ranging from light perception to identifiable visual targets, can be assessed using the VFB-CSN alone. The assessment scale has a maximum score of 60 and a minimum score of 0, with higher scores indicating better performance.

  From enrollment to one year after the end of treatment

• Functional Vision Questionnaire

  This questionnaire is completed by the primary caregiver. It is designed for children with severe central nervous system disorders, such as children with cerebral palsy, to evaluate their visual performance under different brightness conditions and during daily activities. The scale consists of 28 questions, with a maximum score of 140 and a minimum score of 28. Higher scores indicate better performance.

  From enrollment to one year after the end of treatment

• Eye Movement Assessment Behavioral Scale for Children

  The scoring is conducted by occupational therapists with experience in visual rehabilitation, based on their observation of the child's performance. This assessment employs an eye tracker and PowerPoint to create an eye movement assessment program before and after rehabilitation. It evaluates children's abilities in fixation, tracking, and saccadic movements in response to visual stimuli of varying sizes, contrasts, directions, speeds, and positions. The assessment scale has a maximum score of 64 and a minimum score of 8, with higher scores indicating better performance.

  From enrollment to one year after the end of treatment

• Near Detection Scale

  Near Detection Scale (NDS) is performed by clinicians specializing in visual issues among children with special needs to quickly assess the detection acuity of children with severe and profound visual impairment. NDS is an 18-point scale, with 0 representing no light perception and 18 representing the ability to see 0.1 cm objects on a dark green background at a viewing distance of 30 cm. Higher scores indicate better visual acuity.

  From enrollment to one year after the end of treatment

Secondary Outcomes (1)

• Three-Day Daily of Children's Daily Visual Performance

  From enrollment to one year after the end of treatment

Study Arms (2)

Visual rehabilitation group

EXPERIMENTAL

This study includes two distinct groups: one comprising individuals with non-severe visual impairment and the other consisting of individuals with severe or profound visual impairment. The severe/profound visual impairment group receives passive visual stimulation, while the non-severe visual impairment group undergoes visual stimulation using a checkerboard pattern. The latter approach incorporates perceptual learning theories, emphasizing attentional modulation and leveraging the oddball design concept to enhance visual processing and rehabilitation outcomes.

Behavioral: restorative visual rehabitation

Usual care group

NO INTERVENTION

Usual care includes physical games and teaching methods that utilize auditory and tactile senses to compensate for vision.

Interventions

restorative visual rehabitation BEHAVIORAL

black-and-white checkerboard patterns, visual stimulation program, restorative visual rehabitation

Visual rehabilitation group

Eligibility Criteria

• Age: 1 Month - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged less than or equal to 12 years old.
• The causes of visual disorder in children are unlimited.
• The acuity of children's better eye ranges between hand move and 0.2.
• Children with multiple disabilities and visual disorders typically exhibit developmental levels ranging from moderate to severe or below.
• The parents of these children exhibit a positive attitude and are willing to cooperate with visual learning programs.
• Infants under 1 year old with low vision without other developmental issues , under or equal to moderate developmental issues.

You may not qualify if:

• Significant refractive errors that affect acuity but are unable to cooperate with wearing corrective glasses in two training sessions.
• Requires patching for monocular vision rehabilitation but is unable to cooperate with patching in two training sessions.
• The individual is unable to adapt to the training environment and cooperate with visual learning in two sessions due to unstable emotions or difficulty adapting to the environment.
• Children aged less than or equal to 12 years old.
• No restrictions on the causes of visual impairment in children.
• Best-corrected visual acuity (BCVA) in the better eye is equal to or better than 0.02.
• If children have additional developmental issues, their disability severity should primarily be mild or moderate.
• The primary caregiver demonstrates a positive attitude and is willing to cooperate with the visual training program.
• (1)Significant refractive errors that severely affect vision, where the child cannot adapt to wearing corrective glasses within two training sessions.
• (2)Requires occlusion therapy for monocular visual rehabilitation but cannot cooperate with occlusion within two training sessions.
• (3)Inability to adapt to the training environment or cooperate with visual training due to emotional instability or difficulty adjusting within two training sessions.
• (4)Unstable physiological conditions (e.g., epilepsy, sleep disturbances) that prevent consistent participation in visual training.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Occupational Therapy, College of Medicine, National Taiwan University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Blindness, Cortical

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Li-Ting Tsai, PhD

CONTACT

886-2-33668164; litingtsai@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 22, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 14, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)