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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010708
Receipt No. R000012514
Scientific Title A new glaucoma staging system based on visual field index
Date of disclosure of the study information 2013/05/13
Last modified on 2015/07/23

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Basic information
Public title A new glaucoma staging system based on visual field index
Acronym Glaucoma staging system based on VFI
Scientific Title A new glaucoma staging system based on visual field index
Scientific Title:Acronym Glaucoma staging system based on VFI
Region
Japan

Condition
Condition Glaucoma patients
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To present a new glaucoma staging system (GSS) based on the visual field index (VFI) and to evaluate the staging performance of this system compared with that of Bascom Palmer GSS and Enhanced GSS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes VFI cutoff values for each stage
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients who had been examined at Kitasato University Hospital between April 2008 and June 2011.
Patients who had been examined Humphrey Field Analyzer (HFA) program 30-2 Swedish Interactive Threshold Algorithm Standard
Key exclusion criteria Patients whose results had low reliability (fixation loss rates of more than 20%, false positive response rates of more than 15%, and false negative response rates of more than 33%) were excluded, as were those with results that were associated with age-related macular degeneration, diabetic retinopathy, intracranial disease, or corneal disease.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Shoji
Organization Graduate School of Medical Science, Kitasato University
Division name Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa 252-0374, Japan
TEL 042-778-8464
Email nshoji@ahs.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Hirasawa
Organization Graduate school of Medical Science, Kitasato University
Division name Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa 252-0374, Japan
TEL 042-778-8464
Homepage URL
Email hirasawa@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Department of Ophthalmology, Graduate School of Medical Science, Kitasato 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
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 北里大学病院
Kitasato University Hospital

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 03 Month 05 Day
Date of IRB
Anticipated trial start date
2011 Year 07 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 retrospective study

Management information
Registered date
2013 Year 05 Month 13 Day
Last modified on
2015 Year 07 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012514

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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