UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027341 |
|---|---|
| Receipt number | R000031242 |
| Scientific Title | Evaluation Study of Vision-related Essential Skills with WAVES(Wide-range Assessment of Vison-related Essential Skills) in the Children Suspected Higher-order Visual Dysfunction. |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2021/11/22 09:59:24 |
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Basic information
Public title
Evaluation Study of Vision-related Essential Skills with WAVES(Wide-range Assessment of Vison-related Essential Skills) in the Children Suspected Higher-order Visual Dysfunction.
Acronym
Evaluation Study of Vison-related Essential Skills.
Scientific Title
Evaluation Study of Vision-related Essential Skills with WAVES(Wide-range Assessment of Vison-related Essential Skills) in the Children Suspected Higher-order Visual Dysfunction.
Scientific Title:Acronym
Evaluation Study of Vison-related Essential Skills.
Region
| Japan |
Condition
Condition
Psychogenic visually impairment, learning disability, pervasive developmental disorder
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the vision-related essential skills in the children suspected of the psychogenic visually impairment or learning disability or pervasive developmental disorder without eye diseases other than refractive error.
Basic objectives2
Others
Basic objectives -Others
Quantification of the function to understand the information from eyes (spatial perception/cognition, form perception/ cognition, visual memory), and evaluation of the weak points in the individuals.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quantification of the function to understand the information from eyes (spatial perception/cognition, form perception/ cognition, visual memory), and comparison of the value with the children of the same age.
Key secondary outcomes
Quantification of the function to understand the information from eyes (spatial perception/cognition, form perception/ cognition, visual memory), and evaluation of the weak points in the individuals.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention period is only inspection time around 1 hour.
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children suspected of the psychogenic visually impairment, learning disability, or pervasive developmental disorder.
Key exclusion criteria
Children with eye diseases other than refractive error.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Chizu |
| Middle name | |
| Last name | Touge |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Ophthalmology
Zip code
683-0826
Address
36-1 Nishi-cho, Yonago, Tottori 683-8504, JAPAN
TEL
0859-38-6617
mihokan@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Chizu |
| Middle name | |
| Last name | Touge |
Organization
Faculty of Medicine, Tottori University
Division name
Division of Ophthalmology
Zip code
683-0826
Address
36-1 Nishi-cho, Yonago, Tottori 683-8504, JAPAN
TEL
0859-38-6617
Homepage URL
mihokan@med.tottori-u.ac.jp
Sponsor or person
Institute
Division of Ophthalmology.
Faculty of Medicine, Tottori University.
Institute
Department
Personal name
Funding Source
Organization
Division of Ophthalmology.
Faculty of Medicine, Tottori 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
Faculty of Medicine, Tottori University
Address
/36-1 Nishi-cho, Yonago, Tottori 683-8504, JAPAN
Tel
0859-38-6617
mihokan@med.tottori-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
鳥取大学医学部附属病院、野島病院 / Faculty of Medicine, Tottori University, Nojima hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 15 | Day |
Last modified on
| 2021 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031242
