UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047419 |
|---|---|
| Receipt number | R000054078 |
| Scientific Title | Airflow and surgical field contamination in ophthalmic surgery |
| Date of disclosure of the study information | 2022/04/06 |
| Last modified on | 2022/04/06 16:03:32 |
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Basic information
Public title
Airflow and surgical field contamination in ophthalmic surgery
Acronym
Relationship between airflow and surgical field contamination
Scientific Title
Airflow and surgical field contamination in ophthalmic surgery
Scientific Title:Acronym
Relationship between airflow and surgical field contamination
Region
| Japan |
Condition
Condition
bacterial endophthalmitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the surgical field for contamination by airflow in the direction of the eye that occurs during ophthalmic surgery.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between the size of the airflow and the number of bacteria dispersed toward the eye
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
Active infections of the eye, respiratory tract, etc
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Morioka |
Organization
University of Fukui
Division name
ophthalmology
Zip code
9101193
Address
23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776613111
mmorioka@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Morioka |
Organization
University of Fukui
Division name
Ophthalmology
Zip code
9101193
Address
23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776613111
Homepage URL
mmorioka@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
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
The Research Ethics Committee of University of Fukui
Address
23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
Tel
0776613111
mmorioka@u-fukui.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
| 2022 | Year | 04 | Month | 06 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 04 | Month | 06 | Day |
Last modified on
| 2022 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054078
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
