UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019294 |
|---|---|
| Receipt number | 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 09:31:11 |
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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
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
m2fjmt@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022199
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
