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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027694
Receipt No. R000031723
Scientific Title Ocular suface observation with anterior optical coherence tomography
Date of disclosure of the study information 2017/08/01
Last modified on 2017/06/08

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Basic information
Public title Ocular suface observation with anterior optical coherence tomography
Acronym Ocular surface observation with AC-OCT
Scientific Title Ocular suface observation with anterior optical coherence tomography
Scientific Title:Acronym Ocular surface observation with AC-OCT
Region
Japan

Condition
Condition A case with corneal disease
A case with post-keratoplasty
A case with post-glaucoma operation
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the patients who has corneal disease and taken glaucoma operation with anterior optical coherence tomography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Corneal thickness
Anterior chamber angle
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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 To take a picture with anterior OCT for ocular surface disease
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 A case with ocular surface disease
A case with post-glaucoma operation
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuro Miyamoto
Organization Institute of Biomedical Sciences, Tokushima University Graduate School
Division name Department of Ophthalmology
Zip code
Address 3-18-15 Kuramotocho, Tokushima city
TEL 088-633-7163
Email miyatatsu@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuro Miyamoto
Organization Institute of Biomedical Sciences, Tokushima University Graduate School
Division name Department of Ophthalmology
Zip code
Address 3-18-15 Kuramotocho, Tokushima city
TEL 088-633-7163
Homepage URL
Email miyatatsu@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 08 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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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
2017 Year 06 Month 08 Day
Last modified on
2017 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031723

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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