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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031223
Receipt No. R000035455
Scientific Title Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/09

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Basic information
Public title Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.
Acronym Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.
Scientific Title Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.
Scientific Title:Acronym Research for the rate and risk factors of the occurrence of posterior staphyloma from high myopia.
Region
Japan

Condition
Condition high myopia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between posterior staphyloma and high myopia
Basic objectives2 Others
Basic objectives -Others risk factor of posterior staphyloma
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes measure the refraction value, visual acuity, axial length and so on every six months
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Retrospective study: patients who have already developped posterior staphyloma
Prospective study: patients aged between 40 and 50 who have not developped posterior staphyloma in both eyes or have developped posterior staphylpma in one eye
Key exclusion criteria other than those above
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Hieda
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 Kajii-cho,Kamigyo-ku,Kyoto city
TEL 075-251-5578
Email msasaki@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miho Sasaki
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 Kajii-cho,Kamigyo-ku,Kyoto city
TEL 075-251-5578
Homepage URL
Email msasaki@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

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
Email

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
2018 Year 03 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
2017 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective and retrospective study(Observational study)

Management information
Registered date
2018 Year 02 Month 09 Day
Last modified on
2018 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035455

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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