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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025424
Receipt No. R000029266
Scientific Title The quantification of vision-related quality of life (QOL) using VFQ-25 questionnaire
Date of disclosure of the study information 2016/12/27
Last modified on 2017/07/04

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Basic information
Public title The quantification of vision-related quality of life (QOL) using VFQ-25 questionnaire
Acronym The quantification of vision-related QOL using VFQ-25 questionnaire
Scientific Title The quantification of vision-related quality of life (QOL) using VFQ-25 questionnaire
Scientific Title:Acronym The quantification of vision-related QOL using VFQ-25 questionnaire
Region
Japan

Condition
Condition A. Ophthalmic patients with visual disfunction
B. Neurosurgical patients with visual disfunction
C. Every patients with visual disfunction
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the vision-related QOL in patients with various disease.
Basic objectives2 Others
Basic objectives -Others To evaluate the relationship between vision-related QOL and visual disfunction in patients with various disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes vision-related QOL
Key secondary outcomes The relationship between visual acuity and vision-related QOL
The relationship between visual field and vision-related QOL

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 VFQ-25 questionnaire
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

Not applicable
Gender Male and Female
Key inclusion criteria A. Ophthalmic patients with visual disfunction
B. Neurosurgical patients with visual disfunction
C. Every patients with visual disfunction
Key exclusion criteria A. Acute disorder
B. Under 20 age
C. Patients who couldn't understand the VFQ-25 questionnaire
D. Patients ruled unfit to the study by investigatior
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuro Oshika
Organization University of Tsukuba
Division name Department of Ophthalmology, Faculty of Medicine
Zip code
Address 1-1-1 Tennoudai, Tsukuba-city, Ibaraki
TEL 0298533148
Email oshika@eye.ac

Public contact
Name of contact person
1st name
Middle name
Last name Yoshifumi Okamoto
Organization University of Tsukuba
Division name Department of Ophthalmology, Faculty of Medicine
Zip code
Address 1-1-1 Tennoudai, Tsukuba-city, Ibaraki
TEL 0298533148
Homepage URL
Email y-okamoto@md.tsukuba.ac.jp

Sponsor
Institute Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 12 Month 27 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
2009 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information under investigation

Management information
Registered date
2016 Year 12 Month 27 Day
Last modified on
2017 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029266

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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