UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028204 |
|---|---|
| Receipt number | R000032273 |
| Scientific Title | Development and commercialization of a portable perimeter (POLS) that contributes to avoidance of blindness |
| Date of disclosure of the study information | 2017/07/18 |
| Last modified on | 2024/01/20 14:30:46 |
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Basic information
Public title
Development and commercialization of a portable perimeter (POLS) that contributes to avoidance of blindness
Acronym
Development of a portable perimeter
Scientific Title
Development and commercialization of a portable perimeter (POLS) that contributes to avoidance of blindness
Scientific Title:Acronym
Development of a portable perimeter
Region
| Japan |
Condition
Condition
Diseases causing the visual field disturbance ex. glaucoma optic neuropathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and commercialization of a portable perimeter that contributes to avoidance of blindness
Basic objectives2
Others
Basic objectives -Others
The validity of the results of the developed portable perimeter is estimated.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The validity of the results of the developed portable perimeter is estimated.
Key secondary outcomes
Agreement with visual field results of the Humphrey perimeter is estimated.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Visual field test is performed in developed portable perimetry to the cases underwent visual field test in Humphrey perimetry.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The cases underwent visual field test in Humphrey perimetry more than 3 times by a glaucoma patients with early and middle stage.
Key exclusion criteria
end stage glaucoma patient with central visual loss.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsunehiko Ikeda |
Organization
Osaka Medical college
Division name
ophthalmology
Zip code
Address
2-7 Daigaku machi Takatsuki Osaka
TEL
072-683-1221
opt089@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Ueki |
Organization
Osaka Medical college
Division name
ophthalmology
Zip code
Address
2-7 Daigaku machi Takatsuki Osaka
TEL
072-683-1221
Homepage URL
opt089@osaka-med.ac.jp
Sponsor or person
Institute
osaka medical college
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032273
