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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004809
Receipt No. R000005726
Scientific Title The research use of surgically obtained samples from human eyes
Date of disclosure of the study information 2011/03/01
Last modified on 2011/12/30

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Basic information
Public title The research use of surgically obtained samples from human eyes
Acronym The research use of surgically obtained samples from human eyes
Scientific Title The research use of surgically obtained samples from human eyes
Scientific Title:Acronym The research use of surgically obtained samples from human eyes
Region
Japan

Condition
Condition ocular diseases that require surgical treatment
Classification by specialty
Gastroenterology Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study are to understand pathogeneis of ocular diseases and to facilitate development of treatment for ocular diseases using the samples surgically obtained from human eyes.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the expressions of mRNA and protein, changes in microstructure, and immunoresponses
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Samples includig aqueous humor, vitreous, and retinal tissues are obtained during surgery. Surgery is performed as usual.
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 patients with ocular diseases that require surgical treatment
Key exclusion criteria patients not willing to participate in this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sentaro Kusuhara
Organization Kobe University Graduate School of Medicine
Division name Department of Surgery, Division of Ophthalmology
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL +81-78-382-6048
Email

Public contact
Name of contact person
1st name
Middle name
Last name Sentaro Kusuhara
Organization Kobe University Graduate School of Medicine
Division name Department of Surgery, Division of Ophthalmology
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL +81-78-382-6048
Homepage URL
Email kusu@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 神戸大学病院(神戸市)

Other administrative information
Date of disclosure of the study information
2011 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 Terminated
Date of protocol fixation
2011 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 Day
Last follow-up date
2016 Year 03 Month 01 Day
Date of closure to data entry
2016 Year 05 Month 01 Day
Date trial data considered complete
2016 Year 08 Month 01 Day
Date analysis concluded
2016 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 12 Month 30 Day
Last modified on
2011 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005726

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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