UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001005 |
|---|---|
| Receipt number | 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 17:55:36 |
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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
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
tatsuymg@luke.or.jp
Sponsor or person
Institute
Saint Luke's International Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001183
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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