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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019294
Receipt No. R000022199
Scientific Title The clinical utility of next generation optical coherence tomography for accessory visual structurescoherence tomography
Date of disclosure of the study information 2015/12/01
Last modified on 2018/04/11

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Basic information
Public title The clinical utility of next generation optical coherence tomography for accessory visual structurescoherence tomography
Acronym The clinical utility of OCT for accessory visual structures
Scientific Title The clinical utility of next generation optical coherence tomography for accessory visual structurescoherence tomography
Scientific Title:Acronym The clinical utility of OCT for accessory visual structures
Region
Japan

Condition
Condition accessory visual structures
Classification by specialty
Ophthalmology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluating clinical utility of next generation optical coherence tomography for accessory visual structures
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Comparison between normal and disease states in lacrimal apparatus using OCT image
Key secondary outcomes Comparison between benign and malignant eyelid tumor using OCT image

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Evaluating accessory visual structures in disease states using next generation optical coherence tomography
Intervention frequency is 3 times; initial visit, postoperative monnths 2,6.
Interventions/Control_2 Evaluating accessory visual structures in normal states using next generation optical coherence tomography
Intervention frequency is one time.
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
100 years-old >
Gender Male and Female
Key inclusion criteria 1.patients who were diagnosed as lacrimal disease or eyelid tumor in Kyoto university
2.patients who are normal states in accessory visual structures
Key exclusion criteria 1.patients who had allergy caused by rebamipido eye-drop
2.patients who didn't agree with this study
3.patients who were judged to be unsuitable to this study by us
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nagahisa Yoshihisa
Organization Kyoto University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address 54 Shogoin-Kawaracho, Sakyou, Kyoto 606-8507
TEL 075-751-3250
Email nagaeye@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Fujimoto
Organization Kyoto University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address 54 Shogoin-Kawaracho, Sakyou, Kyoto 606-8507
TEL 075-751-3250
Homepage URL
Email m2fjmt@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization japan society for promotion of science
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2015 Year 12 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 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 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 10 Month 09 Day
Last modified on
2018 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022199

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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