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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000026236
Receipt No. R000030135
Scientific Title Changes in Bell's phenomenon after inferior rectus muscle recession in patients with thyroid eye disease.
Date of disclosure of the study information 2017/02/28
Last modified on 2017/02/20

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Basic information
Public title Changes in Bell's phenomenon after inferior rectus muscle recession in patients with thyroid eye disease.
Acronym Bell's phenomenon and inferior rectus muscle recession
Scientific Title Changes in Bell's phenomenon after inferior rectus muscle recession in patients with thyroid eye disease.
Scientific Title:Acronym Bell's phenomenon and inferior rectus muscle recession
Region
Japan

Condition
Condition Thyroid eye disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine changes in Bell's phenomenon after inferior rectus muscle recession in patients with thyroid eye disease.
Basic objectives2 Others
Basic objectives -Others Physiological changes after surgery
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Changes in Bell's phenomenon after inferior rectus muscle recession in patients with thyroid eye disease
Key secondary outcomes Corneal condition, the amount of recession

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
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 Prevention
Type of intervention
Maneuver
Interventions/Control_1 Examination of Bell's phenomenon before and 3 months after surgery
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 eye disease who wii undergo inferior rectus muscle recession.
Key exclusion criteria Patients who do not consent to join the study.
Patients who are inadequate for participation of the study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Takahashi
Organization Aichi Medical University Hospital
Division name Department of Oculoplastic, Orbital and Lacrimal Surgery
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561623311
Email yasuhiro_tak@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobumitsu Oka
Organization Aichi Medical University Hospital
Division name Management section
Zip code
Address 1-1 Yazakokarimata, Nagakute, Aichi, Japan
TEL 0561623311
Homepage URL
Email oka@aichi-med-u.ac.jp

Sponsor
Institute Department of Oculoplastic, Orbital, and Lacrimal Surgery, Aichi Medical University Hospital
Institute
Department

Funding Source
Organization Aichi Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 愛知医科大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 28 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
Date of protocol fixation
2017 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 16 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 02 Month 20 Day
Last modified on
2017 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030135

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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