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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003158
Receipt No. R000003832
Scientific Title A corneal and conjunctival histological investigation with in vivo confocal microscopy
Date of disclosure of the study information 2010/02/09
Last modified on 2013/02/18

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Basic information
Public title A corneal and conjunctival histological investigation with in vivo confocal microscopy
Acronym A corneal and conjunctival histological investigation with in vivo confocal microscopy
Scientific Title A corneal and conjunctival histological investigation with in vivo confocal microscopy
Scientific Title:Acronym A corneal and conjunctival histological investigation with in vivo confocal microscopy
Region
Japan

Condition
Condition Corneal and conjunctival disorders that causes limbal stem cell deficiency
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical efficacy of the diagnosis of corneal and conjunctival disorders using in vivo confocal microscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In vivo confocal microscopy images
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Corneal and conjunctival disorders
Key exclusion criteria 1.Pregnant and lactating woman
2.Drug allergy for this agents
3.Were judged an inadequate subject to enrollment by a medical doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tai-ichiro Chikama
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address 1-1-1 Minami-Kogushi, Ube city, Yamaguchi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yamaguchi University Graduate School of Medicine
Division name Department of Ophthalmology
Zip code
Address
TEL 0836-22-2278
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
2010 Year 02 Month 09 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
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 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 Examine the human cornea with in vivo confocal microscopy.

Management information
Registered date
2010 Year 02 Month 09 Day
Last modified on
2013 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003832

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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