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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036112
Receipt No. R000039842
Scientific Title Fundus shapes with an OCT and myopia
Date of disclosure of the study information 2019/03/06
Last modified on 2019/10/09

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Basic information
Public title Fundus shapes with an OCT and myopia
Acronym Fundus shapes and myopia
Scientific Title Fundus shapes with an OCT and myopia
Scientific Title:Acronym Fundus shapes and myopia
Region
Japan

Condition
Condition Healthy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Relationship between fundus shape and myopia in consideration of age
Basic objectives2 Others
Basic objectives -Others High order aberration, corneal shape, relationship with eye axis length are clarified
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Regression of the curvature distribution of the fundus to myopia and its coefficient of determination
Key secondary outcomes Multiple regression of high order aberration, corneal shape, and axial length to myopia and its coefficient of determination

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Healthy eyes with mild cataract and mild glaucoma
Key exclusion criteria pathological fundus shape change
Target sample size 200

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, Ibaraki, Japan
TEL 0298533148
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, Ibaraki, Japan
TEL 0298533148
Homepage URL
Email mihashi@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Topcon Coporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Univeristy of Tsukuba
Address 1-1-1 Tennodai, Tsukuba
Tel 0298533148
Email mihashi@md.tsukuba.ac.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 筑波大学附属病院(茨城県)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 06 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 01 Month 24 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 07 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measure both eyes of the subjects using two fundus OCTs, a wavefront sensor, an eye axis measuring device, and an anterior segment OCT.

Management information
Registered date
2019 Year 03 Month 06 Day
Last modified on
2019 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039842

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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