UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Causative bacteria and the clinical course in eyes underwent vitrectomy for acute endophthalmitis after intravitreal injection
Title of the study (Brief title)	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	Makoto Inoue
Organization	Kyorin University School of Medicine
Division name	Department of Ophthalmlology
Address	Shinkawa Mitaka Tokyo Japan
TEL	0422-47-5511
Email	inoue@eye-center.org

Public contact
Name of contact person	Tsukasa Mochizuki
Organization	Kyorin University School of Medicine
Division name	Department of Ophthalmlology
Address	Shinkawa, Mitaka, Tokyo, Japan
TEL	0422-47-5511
Homepage URL
Email	mochizuki@eye-center.org

Sponsor
Institute	Kyorin University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032932