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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name