UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013348 |
|---|---|
| Receipt number | R000015496 |
| Scientific Title | Effectiveness ofintraoperative iodine compound disinfection to prevent post operative infection after cataract surgery |
| Date of disclosure of the study information | 2014/03/07 |
| Last modified on | 2017/10/10 16:09:09 |
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Basic information
Public title
Effectiveness ofintraoperative iodine compound disinfection to prevent post operative infection after cataract surgery
Acronym
Effectiveness of intraoperative iodine compound disinfection
Scientific Title
Effectiveness ofintraoperative iodine compound disinfection to prevent post operative infection after cataract surgery
Scientific Title:Acronym
Effectiveness of intraoperative iodine compound disinfection
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate ocular surface flora amount in the surgical field and develop efficient and safe intraoperative antiseptic measure
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial flora amount and colony count in the surgical field
Key secondary outcomes
Base
Study type
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
| Medicine | Maneuver |
Interventions/Control_1
Intraoperative iodine compound disinfection for surgical field
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cataract surgery
Key exclusion criteria
Patients with pre-existing blepharitis, conjunctivitis, keratitis, or uveitis
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Inoue |
Organization
Tottori university
Division name
Division of Ophthalmology and Visual Science
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori
TEL
0859-38-6617
yoinoue@grape.med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dai Miyazaki |
Organization
Tottori university
Division name
Division of Ophthalmology and Visual Science
Zip code
Address
36-1 Nishi-cho, Yonago, Tottori pref.
TEL
0859-38-6617
Homepage URL
dm@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori university, Division of Ophthalmology and Visual Science
Institute
Department
Personal name
Funding Source
Organization
NIHON TENGANYAKU KENKYUSYO CO. LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
野島病院（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 07 | 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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 06 | Day |
Last modified on
| 2017 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015496
