UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045162 |
|---|---|
| Receipt number | R000051471 |
| Scientific Title | Head position monitoring with triaxial accelerometer after ophthalmic surgery |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2022/08/17 11:16:07 |
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Basic information
Public title
Head position monitoring with triaxial accelerometer after ophthalmic surgery
Acronym
Head position monitoring with triaxial accelerometer after ophthalmic surgery
Scientific Title
Head position monitoring with triaxial accelerometer after ophthalmic surgery
Scientific Title:Acronym
Head position monitoring with triaxial accelerometer after ophthalmic surgery
Region
| Japan |
Condition
Condition
ocular diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of effectiveness and safety of head posture monitoring with triaxial accelerometer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
triaxial acceleration values
Key secondary outcomes
Adverse event with the attachment of triaxial accelerometer
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Triaxial accelerometer attached to eye patch is worn by the subject for 7 days.
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
| 5 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients
Patients who need to wear eye patch
Patients with written informed consent and voluntary agreements for the study
Key exclusion criteria
Patients who can not understand the study
Patients without the need to wear eye patch
Any other difficulties that the researchers regard as inappropriate
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Hirano |
Organization
Shinshu University
Division name
Ophthalmology
Zip code
3908621
Address
Nagano, Matsumoto, Asahi, 3-1-1
TEL
0263372664
ieganka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Chiku |
Organization
Shinshu University
Division name
Ophthalmology
Zip code
3908621
Address
Nagano, Matsumoto, Asahi, 3-1-1
TEL
0263372664
Homepage URL
chiku@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
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
Shinshu Univesity, Ophthalmology department
Address
Nagano, Matsumoto, Asahi, 3-1-1
Tel
0263372664
ieganka@shinshu-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 20 | 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
| 2021 | Year | 08 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051471
| 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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