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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001942
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Osaka University Hospital, Department of Ophthalmology
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002363

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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