UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031981 |
|---|---|
| Receipt number | 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 17:04:19 |
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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
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
mganka@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033321
| 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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| Registered date | File name |
