UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002260
Receipt No. R000001673
Scientific Title Disinfection rate for intravitreal injection and
Date of disclosure of the study information 2013/04/01
Last modified on 2010/03/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Disinfection rate for intravitreal injection and
Acronym Disinfection for intravitreal injection
Scientific Title Disinfection rate for intravitreal injection and
Scientific Title:Acronym Disinfection for intravitreal injection
Region
Japan

Condition
Condition Choroidal neovascularization, retinal vein occlusion, diabetic retinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Two methods will be compared in terms of disinfection rate before intravitreal injection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Disinfection rate of the conjunctival sac before injection,
Key secondary outcomes culture positive rate of the injection needle after injection

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Disinfection with 5% povidone iode for conjunctiva and 10% povidone iode for lid
Interventions/Control_2 0.5% levofloxacin eye drops weer applied every 5 minutes 3 times, and then 1.25% povidon iode eyd drops applied every minute 3 times as well as 10% povidone iode for lid
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 Patients receiving intravitreal injection
Key exclusion criteria 1) Intravitreal steroid injection
2) immunocompromised
3) any difficulties when injection
4) any in appropreate condition judged by the physician
5) Atopic dermatitis
6) Iode or levefloxacin allergy
7) Disagreed patients
8) any antibiotic treatment within last 2 weeks
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Ikuno
Organization Osaka University Medical School
Division name Ophthalmology
Zip code
Address 2-2 Yamadaoka, Suita
TEL 06-6879-3456
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Ikuno
Organization Osaka University Medical School
Division name Ophthalmology
Zip code
Address
TEL
Homepage URL
Email ikuno@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Osaka University Medical School
Institute
Department

Funding Source
Organization NA
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
Address
Tel
Email

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
2013 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
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
2008 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2011 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 28 Day
Last modified on
2010 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001673

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.