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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001005
Receipt No. R000001183
Scientific Title Investigation for the Method of Disinfection in Prior Cataract Surgery
Date of disclosure of the study information 2008/02/04
Last modified on 2008/01/31

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Basic information
Public title Investigation for the Method of Disinfection in Prior Cataract Surgery
Acronym Investigation for the Method of Disinfection in Prior Cataract Surgery
Scientific Title Investigation for the Method of Disinfection in Prior Cataract Surgery
Scientific Title:Acronym Investigation for the Method of Disinfection in Prior Cataract Surgery
Region
Japan

Condition
Condition Cataract
Classification by specialty
Ophthalmology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the appropriate method of disinfection in prior cataract surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The negative rate of cultured bacteria the conjunctiva
Key secondary outcomes The assessment of the cornea by fluorescein staining after surgery
The assessment of cells in the anterior chamber with a slit-lamp after surgery
The period for operation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 A group (American method)
After ocular instillation of 0.5% levofloxacin ophthalmic solution 4 times/day for 3 days before surgery, conduct disinfection as follows;
Coat the 10% povidone-iodine on the eyelids and eyelid-surrounding, and dry after wash to make seal on them. Adminidter eye drop on eyes with the 1.25% povidonr-iodine solution.
Interventions/Control_2 B group (St.Luke's method)
After ocular instillation of 0.5% levofloxacin ophthalmic solution 4 times/day for 3 days before surgery, conduct disinfection as follows;
Coat the 10% povidone-iodine on the eyelids and eyelid-surrounding, also on margin of eyelid. Wash the eyelid and eyelid conjunctiva with 0.02% chlorhexidine gluconate in everting. Wash with saline and wipe cleanly to make seal.
Interventions/Control_3 C group (Most popular method of Japan)
After ocular instillation of 0.5% levofloxacin ophthalmic solution 4 times/day for 3 days before surgery, conduct disinfection as follows;
Coat the 10% povidone-iodine on eyelids and eyelid-surrounding, also on margin of eyelid. Wash eye-surrounding with 0.02% chlorhexidine gluconate (not everting). Wash with saline and wipe cleanly to make seal.
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 Cases scheduled for the cataract surgery (PEA + IOL, with limbal incision)
1. senile cataract
2. single cataract surgery
3. virginal eyes
Key exclusion criteria 1. cases with atopy
2. cases treated with systemic antibiotic within 1 week prior surgery
3. cases with intlammation in lid
4. cases with histories of anaphylaxis etc. to the test drugs,
Target sample size 75

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuo Yamaguchi
Organization Saint Luke's International Hospital
Division name Department of ophthalmology
Zip code
Address 9-1 Akashicho chuo-ku Tokyo 104-8560, Japan
TEL 03-3541-5151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuo Yamaguchi
Organization Saint Luke's International Hospital
Division name Department of ophthalmology
Zip code
Address 9-1 Akashicho chuo-ku Tokyo 104-8560, Japan
TEL 03-3541-5151
Homepage URL
Email tatsuymg@luke.or.jp

Sponsor
Institute Saint Luke's International Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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
2008 Year 02 Month 04 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 Preinitiation
Date of protocol fixation
2007 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2008 Year 12 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
2008 Year 01 Month 31 Day
Last modified on
2008 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001183

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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