UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035335 |
|---|---|
| Receipt number | R000038887 |
| Scientific Title | Evaluation of Visual Guidance Based Automated Perimeter |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2023/05/22 21:21:59 |
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Basic information
Public title
Evaluation of Visual Guidance Based Automated Perimeter
Acronym
Evaluation of Visual Guidance Based Automated Perimeter
Scientific Title
Evaluation of Visual Guidance Based Automated Perimeter
Scientific Title:Acronym
Evaluation of Visual Guidance Based Automated Perimeter
Region
| Japan |
Condition
Condition
visual field defect or suspect
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the results of visual guidance based automated perimeter to that of Humphrey Field Analyzer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual field
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Performing visual guidance based automated perimeter once or twice
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
| 18 | years-old | <= |
Age-upper limit
| 130 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1, Visual field defect suspect
2, Patients who undergo Humphrey Field Analyzer atKyoto University Hospital
3, Age of 18 years or more
4, Patients who can agree to participate, in his/her own intention
Key exclusion criteria
None
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Hanako |
| Middle name | |
| Last name | Ikeda |
Organization
Kyoto University Hospital
Division name
Department of Ophthalmology
Zip code
6068507
Address
54, Shogoinkawaharacho, Sakyoku, Kyoto city, Kyoto, Japan
TEL
+81757513248
hanakoi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Miyake |
Organization
Kyoto University Hospital
Division name
Department of Ophthalmology
Zip code
6068507
Address
54, Shogoinkawaharacho, Sakyoku, Kyoto city, Kyoto, Japan
TEL
+81757513248
Homepage URL
miyakem@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
FINDEX
Name of secondary funder(s)
FINDEX
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4642
ethcom@kuhp.kyoto-u.ac.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
| 2019 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 21 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038887
