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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016946
Receipt No. R000019669
Scientific Title Rapid diagnosis for viral infection of the eye using Polymerase Chain Reaction
Date of disclosure of the study information 2015/04/01
Last modified on 2017/10/10

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Basic information
Public title Rapid diagnosis for viral infection of the eye using Polymerase Chain Reaction
Acronym PCR for diagnosis of viral infection of the eye
Scientific Title Rapid diagnosis for viral infection of the eye using Polymerase Chain Reaction
Scientific Title:Acronym PCR for diagnosis of viral infection of the eye
Region
Japan

Condition
Condition Eye disease suspected for human herpes virus infection
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate diagnostic efficacy of real-time PCR for ocular human herpes virus infection .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Viral DNA amount of human herpes viruses
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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Examine patient's aqueous humor or vitreous by real-time PCR.
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 Patient with infectious eye disease suspected for human herpes virus infection
Key exclusion criteria Patient who did not give informed consent
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name MIYAZAKI Dai
Organization Tottori university
Division name Division of Ophthalmology and Visual Science
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori
TEL 0859-38-6617
Email dm@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name MIYAZAKI Dai
Organization Tottori university
Division name Division of Ophthalmology and Visual Science
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori
TEL 0859-38-6617
Homepage URL
Email dm@med.tottori-u.ac.jp

Sponsor
Institute Tottori university Division of Ophthalmology and Visual Science
Institute
Department

Funding Source
Organization Tottori university Division of Ophthalmology and Visual Science
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 04 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 Open public recruiting
Date of protocol fixation
2015 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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

Management information
Registered date
2015 Year 03 Month 27 Day
Last modified on
2017 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019669

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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