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

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National Taiwan University

Status

Enrolling

Conditions

Visual Rehabilitation

Treatments

Behavioral: restorative visual rehabitation

Study type

Interventional

Funder types

Other

Identifiers

NCT06701617
202306050RINC

Details and patient eligibility

About

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.

Full description

We will recruit 200 children with various types and severities of visual disorders. Additionally, we will collect eye movement assessment data using an eye-tracking system from 30 typically developing infants under two years old to validate the oculomotor assessment newly designed for this study. For this component, the reliability of our oculomotor assessment will be validated through test-retest reliability in both typically developing children and children with multiple disabilities and visual impairments who are enrolled in visual rehabilitation.

Enrollment

200 estimated patients

Sex

All

Ages

6 months to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Children aged less than or equal to 12 years old.
  2. The causes of visual disorder in children are unlimited.
  3. The acuity of children's better eye ranges between hand move and 0.2.
  4. Children with multiple disabilities and visual disorders typically exhibit developmental levels ranging from moderate to severe or below.
  5. The parents of these children exhibit a positive attitude and are willing to cooperate with visual learning programs.
  6. Infants under 1 year old with low vision without other developmental issues , under or equal to moderate developmental issues. If they are unable to comply with non-serve VR program, they will be included in the severe/profound VR program.

Exclusion criteria

  1. Significant refractive errors that affect acuity but are unable to cooperate with wearing corrective glasses in two training sessions.
  2. Requires patching for monocular vision rehabilitation but is unable to cooperate with patching in two training sessions.
  3. 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

severe/profound VR
Experimental group
Treatment:
Behavioral: restorative visual rehabitation
non-serve VR
No Intervention group

Trial contacts and locations

1

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Central trial contact

Ting Li Tsai, PhD

Data sourced from clinicaltrials.gov

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