UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Rapid diagnosis for viral infection of the eye using Polymerase Chain Reaction
Title of the study (Brief title)	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	MIYAZAKI Dai
Organization	Tottori university
Division name	Division of Ophthalmology and Visual Science
Address	36-1 Nishi-cho, Yonago, Tottori
TEL	0859-38-6617
Email	dm@med.tottori-u.ac.jp

Public contact
Name of contact person	MIYAZAKI Dai
Organization	Tottori university
Division name	Division of Ophthalmology and Visual Science
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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