UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001942 |
|---|---|
| Receipt number | R000002363 |
| Scientific Title | Vitreous concentration of moxfloxacin and bacterial isolation during vitreous surgery |
| Date of disclosure of the study information | 2009/12/01 |
| Last modified on | 2010/05/21 01:01:10 |
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Basic information
Public title
Vitreous concentration of moxfloxacin and bacterial isolation during vitreous surgery
Acronym
Vitreous concentration of moxfloxacin and bacterial isolation
Scientific Title
Vitreous concentration of moxfloxacin and bacterial isolation during vitreous surgery
Scientific Title:Acronym
Vitreous concentration of moxfloxacin and bacterial isolation
Region
| Japan |
Condition
Condition
Vitreoretinal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The rate of bacterial contamination in the vitreous cavity
Basic objectives2
Others
Basic objectives -Others
To evaluate the vitreous level of moxifloxacin and disinfection rate after preoperative moxifloxacin administration
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of bacterial contamination in the vitreous samples obtained at the beginning and end of surgery
Key secondary outcomes
Vitreous concentration of moxifloxacin and disinfection rate of conjunctival sac
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
preoperative antibiotic administration (moxifloxacin)
Interventions/Control_2
vitrectomy (20-gauge vs. 25-gauge)
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
eyes shceduled for primary vitrectomy
Key exclusion criteria
past history of vitreous surgery (vitrectomized eyes)
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Oshima |
Organization
Osaka University Medical School
Division name
Department of Ophthalmology
Zip code
Address
2-2 Yamadaoka, Suita 5650871, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Oshima |
Organization
Osaka University Medical School
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Osaka University Hospital, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Osaka University Medical School
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.ncbi.nlm.nih.gov/pubmed/20097429
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/20097429
Number of participants that the trial has enrolled
Results
Of the 81 eyes (40 eyes in the 25-gauge MIVS group; 41 eyes in the 20-gauge PPV group), the incidences of positive bacterial isolation at the 4 time points of sample collection were 77.5%, 62.3%, 22.5%, and 0% in the former group and 82.9%, 63.4%, 2.4%, and 0% in the latter group. Although the rate of bacterial contamination of the ocular surface significantly (P=0.001) decreased after preoperative moxifloxacin administration in both groups, transconjunctival 25-gauge MIVS had a significantly (P=0.007) higher incidence of vitreous contamination at the beginning of surgery compared with conventional 20-gauge PPV. The multivariate model showed that 25-gauge MIVS (odds ratio, 11.27; P=0.027; 95% confidence interval, 1.31-96.79) was the factor prognostic of vitreous contamination at the beginning of surgery. Propionibacterium acnes was identified most often in the vitreous samples (80% of cases), which was consistent with the commensal bacteria isolated from the ocular surface.
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
| 2007 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Ophthalmology. 2010 Apr;117(4):811-7.e1. Epub 2010 Jan 25.
Management information
Registered date
| 2009 | Year | 05 | Month | 05 | Day |
Last modified on
| 2010 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002363
