UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062223 |
|---|---|
| Receipt number | R000071210 |
| Scientific Title | A Preliminary Study of the Short-Term Effects of Gaze Feedback on Oculomotor Function |
| Date of disclosure of the study information | 2026/07/14 |
| Last modified on | 2026/07/13 18:10:05 |
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Basic information
Public title
Effects of on-screen gaze feedback on eye movements in children
Acronym
Gaze Feedback Study
Scientific Title
A Preliminary Study of the Short-Term Effects of Gaze Feedback on Oculomotor Function
Scientific Title:Acronym
Gaze Feedback Pilot Study
Region
| Japan |
Condition
Condition
Children with visual perceptual difficulties, including difficulties in reading, writing, or visual search
Classification by specialty
| Pediatrics | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore whether NSUCO scores change after a brief gaze-feedback task using the Tobii Eye Tracker 5, and to evaluate the short-term effects of awareness of gaze position and compensatory head movement on oculomotor task performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Changes in NSUCO scores (ability, accuracy, head movement, and body movement) before and after gaze feedback. Pre- and post-intervention scores will be compared.
Key secondary outcomes
Tobii calibration success rate, task completion rate, participant comprehension, fatigue or refusal, and associations with DTVP-3, visual function, visual perceptual function, neurodevelopmental disorders, low birth weight, and other background factors.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
After two baseline NSUCO assessments, participants will perform saccade and pursuit tasks presented in PowerPoint for approximately 5-10 minutes while viewing their own gaze position on a monitor using the Tobii Eye Tracker 5 connected to a Windows PC. NSUCO will be reassessed immediately after the intervention.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 5 | years-old | <= |
Age-upper limit
| 13 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children attending the Visual Perception Clinic at Tokushima University Hospital who: (1) can complete the NSUCO test; (2) can see stimuli on a monitor; (3) can understand task instructions; and (4) provide written consent personally or through a legally authorized representative.
Key exclusion criteria
Participants will be excluded if: (1) marked visual impairment prevents task completion; (2) fatigue, anxiety, poor physical condition, or other factors make participation difficult; or (3) the principal investigator considers participation inappropriate.20 participants
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Murao |
Organization
Tokushima University Hospital
Division name
Department of Ophthalmology
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima 770-8503, Japan
TEL
+81-88-633-7163
murao.fumiko.2@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Murao |
Organization
Tokushima University Hospital
Division name
Department of Ophthalmology
Zip code
770-8503
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima 770-8503, Japan
TEL
+81-88-633-7163
Homepage URL
murao.fumiko.2@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima University Hospital Ethics Review Committee for Life Science and Medical Research
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima 770-8503, Japan
Tel
088-615-8512
first-ec@tokushima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 13 | Day |
Last modified on
| 2026 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071210
