UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038206 |
|---|---|
| Receipt number | R000043299 |
| Scientific Title | Research on evaluation for verification of technology and performance validity in the development of fixation-free perimeter (including improvement research and performance evaluation, operation training, image and data collection) |
| Date of disclosure of the study information | 2019/10/07 |
| Last modified on | 2021/11/24 11:22:09 |
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Basic information
Public title
Research on evaluation for verification of technology and performance validity in the development of fixation-free perimeter (including improvement research and performance evaluation, operation training, image and data collection)
Acronym
Research on evaluation for verification of technology and performance validity in the development of fixation-free perimeter (including improvement research and performance evaluation, operation training, image and data collection)
Scientific Title
Research on evaluation for verification of technology and performance validity in the development of fixation-free perimeter (including improvement research and performance evaluation, operation training, image and data collection)
Scientific Title:Acronym
Research on evaluation for verification of technology and performance validity in the development of fixation-free perimeter (including improvement research and performance evaluation, operation training, image and data collection)
Region
| Japan |
Condition
Condition
visual field defect or suspect
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of visual field measurement results using a fixation-free perimeter and an existing static automated perimeter
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
Measure visual acuity and refractive power as preparation before examination, and then perform a perimetry test once or multiple times using an existing static automated perimeter and a fixation-free perimeter.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Age of 18 years or more
2.Patients who can agree to participate, in his/her own intention
Key exclusion criteria
A person who has reported that he/she previously had abnormal finding related to his/her visual line (especially the visual fixation) when obtaining consent
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Teruo |
| Middle name | |
| Last name | Aibara |
Organization
FINDEX Inc.
Division name
Business Strategy Dept.
Zip code
105-6133
Address
2-4-1,Hamamatsucho,Minato-ku,Tokyo,Japan
TEL
03-5408-3745
qms@findex.co.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Matsumoto |
Organization
FINDEX Inc.
Division name
Pharmaceutical Affairs Management Office
Zip code
790-0003
Address
4-9-6,Sanbancho,Matsuyama-city,Ehime,Japan
TEL
089-947-3388
Homepage URL
qms@findex.co.jp
Sponsor or person
Institute
FINDEX Inc.
Institute
Department
Personal name
Funding Source
Organization
FINDEX Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
EMC Healthcare Co.,Ltd.
Ehime University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
FINDEX Inc. Research Ethics Committee
Address
2-4-1,Hamamatsucho,Minato-ku,Tokyo,Japan
Tel
03-5408-3745
qms@findex.co.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 | 10 | Month | 07 | 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
52
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 | 09 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 04 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043299
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
