UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041571 |
|---|---|
| Receipt number | R000047418 |
| Scientific Title | Comparison of visual disability grade between Automatic perimetry and Goldmann perimetry |
| Date of disclosure of the study information | 2020/08/27 |
| Last modified on | 2020/08/27 09:36:11 |
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Basic information
Public title
Comparison of visual disability grade between Automatic perimetry and Goldmann perimetry
Acronym
Comparison of visual disability grade between Automatic perimetry and Goldmann perimetry
Scientific Title
Comparison of visual disability grade between Automatic perimetry and Goldmann perimetry
Scientific Title:Acronym
Comparison of visual disability grade between Automatic perimetry and Goldmann perimetry
Region
| Japan |
Condition
Condition
Subjects had been certified as visual disability grade(Japan)
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the test results between Automatic perimetry and Goldmann perimetry in visual impaired patients.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Each test result
Each test time
Fatigue after each test
Key secondary outcomes
Base
Study type
Observational
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects had been certified as visual disability grade.
Subjects who have consented to undergo two tests, Automatic perimetry and Goldmann perimetry, on the same day.
Key exclusion criteria
Under 19.Subjects had not been certified as visual disability grade.
Subjects who cannot agree to take two tests on the same day.
Subjects who find it difficult to test the two visual fields due to cognitive and physical aspects.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yamaguchi |
| Middle name | |
| Last name | Aya |
Organization
Jichi Medical University Saitama Medical Center
Division name
Ophthalmology
Zip code
3308503
Address
1-847, Amanuma-cyou, Omiya ward, Saitama city, Saitama prefecture
TEL
048-647-2111
ortomiya@omiya.jichi.ac.jp
Public contact
Name of contact person
| 1st name | Yamaguchi |
| Middle name | |
| Last name | Aya |
Organization
Jichi Medical University Saitama Medical Center
Division name
Ophthalmology
Zip code
330-8503
Address
1-847, Amanuma-cyou, Omiya ward, Saitama city, Saitama prefecture
TEL
048-647-2111
Homepage URL
ortomiya@omiya.jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University Saitama Medical Center
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
Jichi Medical University Saitama Medical Center
Address
1-847, Amanuma-cyou, Omiya ward, Saitama city, Saitama prefecture
Tel
048-647-2111
ortomiya@omiya.jichi.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
| 2020 | Year | 08 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
26
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 | 11 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 04 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We randomly divide two groups. One group starts to examine Automatic perimetry at first, the other firstly begins to test Goldmann perimetry. Each test should be performed on the same day, with taking a break at least 30 minutes between each test. Then ask them to answer several questions to assess their fatigue . It will take 90-100 minutes to complete everything.
Management information
Registered date
| 2020 | Year | 08 | Month | 27 | Day |
Last modified on
| 2020 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047418
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
