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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000041025
Receipt No. R000046847
Scientific Title Visual ADL Research
Date of disclosure of the study information 2020/07/08
Last modified on 2020/07/08

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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
Email 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
Email yokouchi123@peace.ocn.ne.jp

Sponsor
Institute Ministry of Health, Labor and Welfare
Institute
Department

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
Email 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 Suspended
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
2020 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046847

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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