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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026745
Receipt No. R000030705
Scientific Title Prospective study of ocular surface diseases
Date of disclosure of the study information 2017/03/28
Last modified on 2017/03/28

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Basic information
Public title Prospective study of ocular surface diseases
Acronym Prospective study of ocular surface diseases
Scientific Title Prospective study of ocular surface diseases
Scientific Title:Acronym Prospective study of ocular surface diseases
Region
Japan

Condition
Condition Ocular surface diseases
Classification by specialty
Ophthalmology Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of clinical factors post treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity
Key secondary outcomes Corneal endothelial density, Central corneal thickness, Severity of conjunctival injection, foveal thickness, cytokine in anterior chamber

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Post treatment for ocular surface diseases
Key exclusion criteria Patients who disagree to be involved in the study
Target sample size 2500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Inatomi
Organization Kyoto Prefectural University of Medicine
Division name Ophthalmology
Zip code
Address 465 Kawaramachi Hirokoji Kamigyo-ku Kyoto Japan
TEL 075-251-5578
Email tinatomi@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Kitazawa
Organization Kyoto Prefectural University of Medicine
Division name Ophthalmology
Zip code
Address 465 Kawaramachi Hirokoji Kamigyo-ku Kyoto Japan
TEL 075-251-5578
Homepage URL
Email kkitazaw@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
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
2017 Year 03 Month 28 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 Open public recruiting
Date of protocol fixation
2012 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information visual acuity

Management information
Registered date
2017 Year 03 Month 28 Day
Last modified on
2017 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030705

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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