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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000025415
Receipt No. R000029255
Scientific Title Open globe injury in Japan
Date of disclosure of the study information 2016/12/26
Last modified on 2017/12/27

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Basic information
Public title Open globe injury in Japan
Acronym Open globe injury in Japan
Scientific Title Open globe injury in Japan
Scientific Title:Acronym Open globe injury in Japan
Region
Japan

Condition
Condition open globe injury
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the characteristics and visual prognosis of open globe injury in Japan.
Basic objectives2 Others
Basic objectives -Others statistics of the disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes causative role
final visual acuity
surgical procedure
Key secondary outcomes preoperative visual acuity
location of injury
cause of bad prognosis

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
1 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Open globe injury patients who received ocular surgery.
Key exclusion criteria When the main outcome measure were not described.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumiki Okamoto
Organization University of Tsukuba
Division name Department of Ophthalmology, Faculty of Medicine
Zip code
Address 1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL 0298533148
Email fumiki-o@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshifumi Okamoto
Organization University of Tsukuba
Division name Department of Ophthalmology, Faculty of Medicine
Zip code
Address 1-1-1 Tennoudai, Tsukuba, Ibaraki
TEL 0298533148
Homepage URL
Email y-okamoto@md.tsukuba.ac.jp

Sponsor
Institute Department of Ophthalmology, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2016 Year 12 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially 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 Suspended
Date of protocol fixation
2016 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2020 Year 03 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information under investigation

Management information
Registered date
2016 Year 12 Month 26 Day
Last modified on
2017 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029255

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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