UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028939
Receipt number R000032932
Scientific Title Causative bacteria and the clinical course in eyes underwent vitrectomy for acute endophthalmitis after intravitreal injection
Date of disclosure of the study information 2017/08/31
Last modified on 2017/08/31 17:37:10

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Basic information

Public title

Causative bacteria and the clinical course in eyes underwent vitrectomy for acute endophthalmitis after intravitreal injection

Acronym

Causative bacteria of acute endophthalmitis after intravitreal injection

Scientific Title

Causative bacteria and the clinical course in eyes underwent vitrectomy for acute endophthalmitis after intravitreal injection

Scientific Title:Acronym

Causative bacteria of acute endophthalmitis after intravitreal injection

Region

Japan


Condition

Condition

acute endophthalmitis after intravitreal injection

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate visual prognosis and clinical
course ofacute endophthalmitis after intravitreal injection

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

visual prognosis

Key secondary outcomes

Species of pathogenic bacteria


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

acute endophthalmitis after intravitreal injection

Key exclusion criteria

none

Target sample size

6


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Inoue

Organization

Kyorin University School of Medicine

Division name

Department of Ophthalmlology

Zip code


Address

Shinkawa Mitaka Tokyo Japan

TEL

0422-47-5511

Email

inoue@eye-center.org


Public contact

Name of contact person

1st name
Middle name
Last name Tsukasa Mochizuki

Organization

Kyorin University School of Medicine

Division name

Department of Ophthalmlology

Zip code


Address

Shinkawa, Mitaka, Tokyo, Japan

TEL

0422-47-5511

Homepage URL


Email

mochizuki@eye-center.org


Sponsor or person

Institute

Kyorin University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

2017 Year 08 Month 31 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

No longer recruiting

Date of protocol fixation

2017 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

From April 2010 to March 2017, we investigated cases of vitreous surgery for endophthalmitis after intravitreal injection of anti-VEGF drugs from the medical record . We also examined the incidence of endophthalmitis after intravitreal injection based on the number of intravitreal injections of anti - VEGF drugs within the same period.


Management information

Registered date

2017 Year 08 Month 31 Day

Last modified on

2017 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032932


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name