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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038514
Receipt No. 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

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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
Email 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
Email tmihashi@live.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043605

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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