UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038514 |
|---|---|
| Receipt number | R000043605 |
| Scientific Title | Confirm accuracy and precision of an integrated measurement instrument for objective Refraction, Axial length, and fundus shape |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2019/11/07 17:31:45 |
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Basic information
Public title
Confirm accuracy and precision of an integrated measurement instrument for objective Refraction, and axial length, etc.
Acronym
Confirm accuracy of an ophthalmology measurement instrument
Scientific Title
Confirm accuracy and precision of an integrated measurement instrument for objective Refraction, Axial length, and fundus shape
Scientific Title:Acronym
Confirm accuracy of an ophthalmology measurement instrument
Region
| Japan |
Condition
Condition
Myopia
Classification by specialty
| Ophthalmology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of an instrument for measuring objective refraction, and axial length etc.
Basic objectives2
Others
Basic objectives -Others
Confirming accuracy and precision of an instrument
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Spherical error and astigmatism of objective refraction, corneal topography, and axial length etc.
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of unapproved medical device
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
| 7 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No pathological disease other than abnormal refraction
Key exclusion criteria
Funfus disease, Disease of anterior part.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tetsuro |
| Middle name | |
| Last name | Oshika |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba
TEL
029-853-3148
oshika@eye.ac
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Mihashi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba
TEL
029-853-3148
Homepage URL
tmihashi@live.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Topcon Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba
Tel
029-853-3148
tmihashi@live.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 | 01 | Month | 01 | 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
| 2019 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | 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 | 11 | Month | 07 | Day |
Last modified on
| 2019 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043605
