UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063294 |
|---|---|
| Receipt number | R000072448 |
| Scientific Title | Effects of short-term training using a handheld eye movement training device on smooth pursuit eye movements in healthy adults |
| Date of disclosure of the study information | 2026/10/15 |
| Last modified on | 2026/10/15 15:49:36 |
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Basic information
Public title
A study of the effects of short-term training using a handheld eye movement training device on the ability to follow moving objects with the eyes
Acronym
Handheld eye movement training study
Scientific Title
Effects of short-term training using a handheld eye movement training device on smooth pursuit eye movements in healthy adults
Scientific Title:Acronym
Effects of handheld eye movement training on smooth pursuit eye movements
Region
| Japan |
Condition
Condition
No specific disease(healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effects of short-term repeated training using a newly developed handheld eye movement training device on horizontal and vertical smooth pursuit eye movements in healthy adults. The study will also evaluate the test-retest reliability and measurement error of eye movement measurements obtained using an eye movement tracking device, as well as the safety and feasibility of the training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Smooth pursuit gain measured using an eye-tracking device in the horizontal and vertical directions. Changes in pursuit gain from T2 (before eye movement training at the second visit) to T4 (after completion of all six training blocks at the third visit) will be evaluated. The mean of three trials for each direction at each measurement time point will be used for analysis.
Key secondary outcomes
Secondary outcomes include the gaze-target agreement rate (percentage of valid samples in which gaze position is within 2 degrees of the target center), number and rate of saccades during pursuit, interocular differences in pursuit gain, gain error, and direction-specific eye movement parameters. Eye movement parameters will also be measured at T3 (before additional training at the third visit) to assess changes during the training period. Between-day reliability will be evaluated using measurements obtained at T1 (first visit) and T2 (before training at the second visit), while within-session reliability will be assessed using three repeated trials at each measurement time point. Reliability and measurement error will be evaluated using intraclass correlation coefficients (ICC), standard error of measurement (SEM), 95% minimal detectable change (MDC95), Bland Altman analysis, and coefficients of variation. Training completion rate, valid data acquisition rate, and subjective symptoms, including eye strain, headache, dizziness, diplopia, and blurred vision, will also be evaluated to assess the safety and feasibility of the training.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Short-term eye movement training will be performed using a newly developed handheld eye movement training device. Participants will follow a moving target presented 40 cm in front of their eyes while seated, with both eyes open and with minimal head movement. The target will be moved horizontally and vertically at a speed of 50 degrees per second.Each training block will consist of three sets of 16 seconds of horizontal tracking (eight cycles), a 15-second rest, 16 seconds of vertical tracking (eight cycles), and another 15-second rest, lasting approximately 3 minutes and 6 seconds per block. Participants will complete three training blocks at the second visit and three additional blocks at the third visit, 3 days later, for a total of six blocks. A 5-minute rest will be provided between blocks.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults aged 18 to 30 years who are students at Kitasato University
2. Individuals with visual acuity of 1.0 or better, either uncorrected or corrected with contact lenses
3. Individuals who provide written informed consent after receiving an explanation of the study
Key exclusion criteria
1.Individuals with ocular diseases that may affect eye movements
2.Individuals with manifest strabismus
3.Individuals with a history of amblyopia, except those diagnosed as having resolved amblyopia
4.Individuals who have undergone ophthalmic surgery within one year before study participation
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Handa |
Organization
Kitasato University
Division name
School of Allied Health Sciences, Department of Rehabilitation, Orthoptics and Visual Science
Zip code
2520373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
0427788874
thanda@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Handa |
Organization
Kitasato University
Division name
School of Allied Health Sciences, Department of Rehabilitation, Orthoptics and Visual Science
Zip code
2520373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
0427788874
Homepage URL
thanda@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato 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
The Research Ethics Committee of Kitasato University School of Allied Health Sciences
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
0427787756
sa-ken9@kitasato-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 | 10 | Month | 15 | 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 | 09 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 06 | 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 | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072448
