UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061625 |
|---|---|
| Receipt number | R000070506 |
| Scientific Title | Investigation of the effects of continuing or discontinuing "Vision-Cognition-Motor Integration Vision Training" on the expansion of visual field function, changes in sensitivity, and their duration |
| Date of disclosure of the study information | 2026/05/19 |
| Last modified on | 2026/05/19 09:49:14 |
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Basic information
Public title
Investigation of the effects of continuing or discontinuing "Vision-Cognition-Motor Integration Vision Training" on the expansion of visual field function, changes in sensitivity, and their duration
Acronym
Investigation of the effects of continuing or discontinuing "Vision-Cognition-Motor Integration Vision Training" on the expansion of visual field function, changes in sensitivity, and their duration
Scientific Title
Investigation of the effects of continuing or discontinuing "Vision-Cognition-Motor Integration Vision Training" on the expansion of visual field function, changes in sensitivity, and their duration
Scientific Title:Acronym
Investigation of the effects of continuing or discontinuing "Vision-Cognition-Motor Integration Vision Training" on the expansion of visual field function, changes in sensitivity, and their duration
Region
| Japan |
Condition
Condition
Individuals without disabilities
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effects of continuing or discontinuing the vision training on the expansion of visual field function, changes in sensitivity, and their duration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Goldmann Perimeter
Evaluation method: Among visual function indices, visual field function was evaluated by examining changes in expansion and sensitivity (threshold) across eight meridians, using data obtained through standard measurement procedures. Measurements were performed by presenting light stimuli from the periphery toward the center under luminance conditions V-4, II-4, and I-4, and were conducted for both binocular and monocular vision.
2. Simplified visual field test device
Evaluation method: Among visual function indices, visual field function was assessed by examining changes in the extent of expansion across eight meridians, using data obtained during routine measurement procedures. The measurements were performed by presenting the visual target from the periphery toward the center.
Key secondary outcomes
Dynamic visual acuity, depth perception, and training performance indices as visual function indicators will be evaluated using data obtained during the routine measurement process.
1.Kinetic vision
2.Depth perception
3.Metronome (eye movement)
4.Switch focus (near-far accommodation)
5.Center point (convergence)
6.360 catch
7.Juggling
8.HECOstix
9.Balance bridge
10.FitLights TM
11.Subjective satisfaction (VAS scale) questionnaire survey (VFQ-25)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults with functional vision sufficient for daily life
Key exclusion criteria
1)Individuals with a medical history that may affect visual function (ocular diseases, history of ocular surgery, etc.).
2)Individuals deemed to have conditions that may interfere with training or measurements.
3)Individuals judged as ineligible by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Ichikawa |
Organization
Chukyo Eye Clinic
Division name
Chukyo Eye Clinic
Zip code
456-0032
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya city, Aichi
TEL
052-883-1543
ichikawa@chukyogroup.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Arai |
Organization
VT LAB.
Division name
Business office
Zip code
162-0845
Address
7th floor of Kuipo bldg. 2-1 Honmura-cho Ichigaya, Shinjuku-ku, Tokyo (within KYODO CO., LTD.)
TEL
070-6645-6788
Homepage URL
lino-vision@outlook.jp
Sponsor or person
Institute
VT LAB.
Institute
Department
Personal name
Funding Source
Organization
VT LAB.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chukyo Eye Clinic Ethics Committee
Address
12-22 Sanbonmatsu-cho Atsuta-ku, Nagoya city, Aichi
Tel
052-884-7976
rec@chukyogroup.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
VT LAB. (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study investigating the effects of continuation or discontinuation of "vision-Cognition-Motor Integration Vision Training" on visual field function using data obtained during the routine training and measurement process.
Management information
Registered date
| 2026 | Year | 05 | Month | 19 | Day |
Last modified on
| 2026 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070506
