UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041025 |
|---|---|
| Receipt number | R000046847 |
| Scientific Title | Visual ADL Research |
| Date of disclosure of the study information | 2020/07/08 |
| Last modified on | 2021/04/20 13:20:35 |
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Basic information
Public title
Visual ADL Research
Acronym
Visual ADL Research
Scientific Title
Visual ADL Research
Scientific Title:Acronym
Visual ADL Research
Region
| Japan |
Condition
Condition
RP
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Regarding the classification of grades of disability, we have evaluated the visual function and ADL in order to examine whether one-eye blindness or blepharospasm is not recognized as a disability according to the current standards, and to evaluate whether these should be linked to the science. Conduct research that can be used to improve the recognition criteria for disability, by collecting statistical knowledge.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The post-rush conversion scores of LVFDL and LVADL as LVFAM for activities of daily living of the visually impaired. Comparison is made between the one-eye group and the control group, and the blepharospasm group and the control group, respectively.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases of Japanese males and females aged 20 to less than 65 and who meet each of the following conditions:
1) One eye group: Those who have an eyeball fistula or corrected vision of 0.02 or less in one eye and do not meet the criteria for recognition of visual impairment of persons with physical disabilities (the criteria after the revision in July 2018) (that is, correction of the other eye) Patients with visual acuity of 0.7 or more)
2) Blepharospasm group: Blepharospasm severity classification Grade 3 to 5 eyelid convulsions, but those who do not meet the criteria for recognition of visual impairment of the physically disabled and patients in the stable period after treatment.
3) Control group: A person who meets the 6th grade of the certification criteria for the physically handicapped person with visual impairment, or a visually impaired person (regardless of the name of eye disease) who falls under the 6th certification criteria.
Key exclusion criteria
Those who meet any of the following conditions are not eligible.
1) New patient
2) Those with significant changes in symptoms and findings
3) Since it is a visual impairment-related ADL survey, it is handicapped, deaf, dementia, etc., and if a substitute is required for a deputy
4) Those who have obtained a certificate of the physically disabled other than visually impaired
5) Those who cannot understand the content and procedures of this research
6) Those who are participating in other research
7) Persons who have difficulty visiting the hospital
8) In addition, those who are judged to be ineligible to carry out this research safely by the principal investigator or researchers.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Yamamoto |
Organization
Chiba University Graduate School of Medicine
Division name
Ophthalmology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi
TEL
043-226-2124
shuyama@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Yokouchi |
Organization
Chiba University Graduate School of Medicine
Division name
Ophthalmology
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi
TEL
043-226-2124
Homepage URL
yokouchi123@peace.ocn.ne.jp
Sponsor or person
Institute
Ministry of Health, Labor and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi
Tel
043-222-7171
prc-jim@chiba-u.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
| 2020 | Year | 07 | Month | 08 | 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
| 2019 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2020 | Year | 07 | Month | 07 | Day |
Last modified on
| 2021 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046847
