UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051137 |
|---|---|
| Receipt number | R000056967 |
| Scientific Title | Development of a gaze control training method for people with visual impairment by using a gaze position feedback system |
| Date of disclosure of the study information | 2023/05/25 |
| Last modified on | 2023/05/23 13:25:20 |
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Basic information
Public title
Development of a gaze control training method for visually impaired persons
Acronym
Gaze control training for visually impaired persons
Scientific Title
Development of a gaze control training method for people with visual impairment by using a gaze position feedback system
Scientific Title:Acronym
Gaze control training for visually impaired persons by using gaze position feedback
Region
| Japan |
Condition
Condition
Visual impairment
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our aim is to develop a gaze control training method for people with visual impairment by sensory feedback.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distance between a predetermined and actual gaze locations
Key secondary outcomes
Coordination of eye movement between the left and right eye, periodic components in gaze position time series, the mode value of the eye movement velocity bands
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
| Behavior,custom |
Interventions/Control_1
Gaze control training
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People who satisfy the criteria for people with visual impairment and adults without visual and auditory impairments interfere with daily activities
Key exclusion criteria
1) People who show discrepancies between the results of visual acuity/visual field tests and those of other ophthalmic examinations
2) People whom researchers decide unsuitable for this research
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yokota |
Organization
Kobe City Eye Hospital
Division name
Clinical division
Zip code
6500047
Address
2-1-8 Minatojima Minamimachi, Chuo-ku, Kobe, Hyogo
TEL
078-381-9876
satoshi_yokota@kcho.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Nakadomari |
Organization
Ritsumeikan University
Division name
Research Organization of Science and Technology
Zip code
5258577
Address
1-1-1 Noji-Higashi, Kusatsu, Shiga
TEL
077-599-4175
Homepage URL
sat-sin1@fc.ritsumei.ac.jp
Sponsor or person
Institute
Kobe City Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Kobe City Medical Center General Hospital Research Ethics Committee
Address
2-1-1 Minatojima Minamimachi Chuo-ku, Kobe, Hyogo
Tel
078-302- 5176
rinken@kcho.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
| 2023 | Year | 05 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056967
