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Recruiting NCT06701617

NCT06701617 In-person and Telehealth Visual Rehabilitation for Children With Low Vision

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Clinical Trial Summary
NCT ID NCT06701617
Status Recruiting
Phase —
Sponsor National Taiwan University Hospital
Condition Visual Rehabilitation
Study Type INTERVENTIONAL
Enrollment 200 participants
Start Date 2024-11-25
Primary Completion 2027-05-31

Eligibility & Interventions

Sex All sexes
Min Age 1 Month
Max Age 18 Years
Study Type INTERVENTIONAL
Interventions
restorative visual rehabitation

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 200 participants in total. It began in 2024-11-25 with a primary completion date of 2027-05-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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

Eligibility Criteria

Passive visual stimulation group Inclusion Criteria: 1. Children aged less than or equal to 18 years old. 2. The causes of visual disorder in children are unlimited. 3. The acuity of the children's better eye was ≤ 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. 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. Perceptual learning group Inclusion Criteria (1)Children aged less than or equal to 12 years old. (2)No restrictions on the causes of visual impairment in children. (3)The acuity of the children's better eye was ≤ 0.5 (4)If children have additional developmental issues, their disability severity should primarily be mild or moderate. (5)The primary caregiver demonstrates a positive attitude and is willing to cooperate with the visual training program. (6)The child is capable of completing calibration with an eye-tracking device. Exclusion Criteria 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.

Contact & Investigator

Central Contact

Li-Ting Tsai, PhD

✉ litingtsai@ntu.edu.tw

📞 886-2-33668164

Frequently Asked Questions

Who can join the NCT06701617 clinical trial?

This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Visual Rehabilitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06701617 currently recruiting?

Yes, NCT06701617 is actively recruiting participants. Contact the research team at litingtsai@ntu.edu.tw for enrollment information.

Where is the NCT06701617 trial being conducted?

This trial is being conducted at Taipei, Taiwan.

Who is sponsoring the NCT06701617 clinical trial?

NCT06701617 is sponsored by National Taiwan University Hospital. The trial plans to enroll 200 participants.

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