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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorNational Taiwan University Hospital

About this trial

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. For both objectives, the visual stimulation intervention will be provided through either in-person or remote delivery

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged less than or equal to 18 years old.

The causes of visual disorder in children are unlimited.

The acuity of the children's better eye was ≤ 0.2.

Children with multiple disabilities and visual disorders typically exhibit developmental levels ranging from moderate to severe or below.

Disqualifiers

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.

Significant refractive errors that severely affect vision, where the child cannot adapt to wearing corrective glasses within two training sessions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • restorative visual rehabitation

    Behavioral

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Visual rehabilitation groupExperimental treatment 1 intervention
Group B: Usual care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to one year after the end of treatment
2

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.

Time frame
From enrollment to one year after the end of treatment
3

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.

Time frame
From enrollment to one year after the end of treatment
4

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.

Time frame
From enrollment to one year after the end of treatment

Secondary outcomes

1

Three-Day Daily of Children's Daily Visual Performance

This record is completed by the primary caregiver to document the child's visual behavior at home. The recording is conducted both before and after training to simultaneously capture the child's training activities and response status at home.

Time frame
From enrollment to one year after the end of treatment

Other outcomes

Sponsors and contacts

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