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


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 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


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

Value
https://center6.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