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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031981
Receipt No. R000033321
Scientific Title Consideration of tear embironment and bacterial detection rate by the difference of lacrimal washing methods after lacrimal operation
Date of disclosure of the study information 2018/04/01
Last modified on 2019/04/01

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Basic information
Public title Consideration of tear embironment and bacterial detection rate by the difference of lacrimal washing methods after lacrimal operation
Acronym Consideration of tear embironment and bacterial detection rate by difference of postoperating lacrimal washing methods
Scientific Title Consideration of tear embironment and bacterial detection rate by the difference of lacrimal washing methods after lacrimal operation
Scientific Title:Acronym Consideration of tear embironment and bacterial detection rate by difference of postoperating lacrimal washing methods
Region
Japan

Condition
Condition lacrimal obstructive disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate the difference in tube infection rate, bacterial detection rate, reocclusion rate and tear film environment after lacrimal obstructive surgery between saline solution washing group and 0.25% diluted iodine solution washing group
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Lacrimal tube infection rate and bacterial detection rate 2 months after surgery
Key secondary outcomes Reocclusion rate 1 year after surgery
Tear film environment pre and 2 months after the surgery; slit-lamp examination, shirmer-1 test, tear meniscus height and area with OCT, strip meniscometry ,tear osmolarity and tearfilm inflammation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 lacrimal washing by saline solution every 2 weeks during 2 months after surgery
Interventions/Control_2 lacrimal washing by 0.25% iodine solution every 2 weeks during 2 months after surgery
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 The patients who undergone lacrimal tube implantation surgery for lacrimal obstructive disease
Key exclusion criteria iodine allergy
not obtein informed consent
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Sho
Middle name
Last name Ishikawa
Organization Saitama Medical university
Division name Department of Ophthalmology
Zip code 350-0495
Address 38 Morohongo Moroyama-machi
TEL 049-295-1295
Email sho_ijp@saitama-med.ac.jp

Public contact
Name of contact person
1st name Osamu
Middle name
Last name Ishihara
Organization Saitama Medical university
Division name Hospital IRB Committee Secretariat
Zip code 350-0495
Address 38 Morohongo Moroyama-machi
TEL 049-276-1354
Homepage URL http://www.saitama-med.ac.jp/hospital/outline/irb_kouhou.html
Email mganka@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medica University
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 Hospital IRB Committee Secretariat
Address 38 Morohongo, Moroyama-cho,Iruma, Saitama
Tel 049-276-1354
Email mganka@saitama-med.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
2018 Year 04 Month 01 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 58
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 Completed
Date of protocol fixation
2017 Year 11 Month 01 Day
Date of IRB
2017 Year 11 Month 06 Day
Anticipated trial start date
2017 Year 11 Month 06 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 02 Month 01 Day
Date trial data considered complete
2019 Year 02 Month 01 Day
Date analysis concluded
2019 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 29 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033321

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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