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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028204
Receipt No. 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 2017/07/19

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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
Email 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
Email opt089@osaka-med.ac.jp

Sponsor
Institute osaka medical college
Institute
Department

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
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

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 Preinitiation
Date of protocol fixation
2017 Year 07 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 18 Day
Last follow-up date
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
2017 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032273

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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