UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010708 |
|---|---|
| Receipt number | 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 09:59:47 |
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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
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
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012514
