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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
