UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038046 |
|---|---|
| Receipt number | R000043368 |
| Scientific Title | Relationship between intraocular pressure changes during abduction and anterior segment optical coherence tomographic findings in thyroid eye disease. |
| Date of disclosure of the study information | 2019/09/19 |
| Last modified on | 2019/09/18 21:02:22 |
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Basic information
Public title
Relationship between intraocular pressure changes during abduction and anterior segment optical coherence tomographic findings in thyroid eye disease.
Acronym
IOP changes and OCT in TED
Scientific Title
Relationship between intraocular pressure changes during abduction and anterior segment optical coherence tomographic findings in thyroid eye disease.
Scientific Title:Acronym
IOP changes and OCT in TED
Region
| Japan |
Condition
Condition
Thyroid eye disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure intraocular pressure changes during abduction, to capture anterior segment optical coherence tomographic images of globe deformation by medial rectus muscle push, and to analyze the relationship between them.
Basic objectives2
Others
Basic objectives -Others
Hypothesis corroboration
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraocular pressure changes during abduction and anterior segment optical coherence tomographic findings
Key secondary outcomes
The relationship between intraocular changes and anterior segment optical coherence tomographic findings.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Intraocular pressure examination and anterior segment optical coherence tomography: 1 time
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
Patients with thyroid-associated medial rectus myopathy confirmed by imaging study.
Key exclusion criteria
Patients aged under 20 years.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Takahashi |
Organization
Aichi Medical University Hospital
Division name
Oculoplastic, Orbital & Lacrimal Surgery
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
yasuhiro_tak@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Watanabe |
Organization
Aichi Medical University Hospital
Division name
Hospital Management Section
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
amu_ethics@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
Aichi Medical University Hospital
Address
1-1 Yazakokarimata, Nagakute, Aichi, Japan
Tel
0561-62-3311
amu_ethics@aichi-med-u.ac.jp
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
愛知医科大学病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 19 | 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
| 2019 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 18 | Day |
Last modified on
| 2019 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043368
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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