UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016055 |
|---|---|
| Receipt number | R000018082 |
| Scientific Title | Evaluation of detection power and utility of OCTOPUS600 perimeter for patients with glaucoma |
| Date of disclosure of the study information | 2014/12/25 |
| Last modified on | 2017/06/26 18:22:23 |
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Basic information
Public title
Evaluation of detection power and utility of OCTOPUS600 perimeter for patients with glaucoma
Acronym
Evaluation of detection power and utility of OCTOPUS600 perimeter
Scientific Title
Evaluation of detection power and utility of OCTOPUS600 perimeter for patients with glaucoma
Scientific Title:Acronym
Evaluation of detection power and utility of OCTOPUS600 perimeter
Region
| Japan |
Condition
Condition
glaucoma patient
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the perimetric finding with OCTOPUS600 and Humphrey perimetr.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of actual threshold and mean deviation.
Size of visual field defect.
Depth of visual feild defect.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
visual field measurement
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
Patient have central fixation and reliable perimetric result in Humphrey perimeter.
Key exclusion criteria
more than 30% of false positive response with OCTOPUS perimeter
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shoji |
Organization
School of Allied Health Sciences, Kitasato University
Division name
Orthoptics and Visual Science, Department of Rehabilitation
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374
TEL
042-448-9671
nshoji@ahs.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Hirasawa |
Organization
School of Allied Health Sciences, Kitasato University
Division name
Orthoptics and Visual Science, Department of Rehabilitation
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374
TEL
+81427789671
Homepage URL
hirasawa@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
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
| 2014 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 06 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 25 | Day |
Last modified on
| 2017 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018082
