UMIN-CTR Clinical Trial

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
Email	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
Email	mmorioka@u-fukui.ac.jp

Sponsor
Institute	University of Fukui
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054078