In-person and Telehealth Visual Rehabilitation for Children With Low Vision (NCT06701617) | Clinical Trial Compass
RecruitingNot Applicable
In-person and Telehealth Visual Rehabilitation for Children With Low Vision
Taiwan200 participantsStarted 2024-11-25
Plain-language 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.
Who can participate
Age range
1 Month – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Function Battery for Children with Special Needs
Timeframe: From enrollment to one year after the end of treatment
2
Functional Vision Questionnaire
Timeframe: From enrollment to one year after the end of treatment
3
Eye Movement Assessment Behavioral Scale for Children
Timeframe: From enrollment to one year after the end of treatment
4
Near Detection Scale
Timeframe: From enrollment to one year after the end of treatment
. 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.