UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000025978
Receipt No. R000029793
Official scientific title of the study transition of surgical outcome in eyes underwent vitrectomy for acute endopthalmitis after cataract surgery
Date of disclosure of the study information 2017/02/06
Last modified on 2017/02/02 (Ver. 2)

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Basic information
Official scientific title of the study transition of surgical outcome in eyes underwent vitrectomy for acute endopthalmitis after cataract surgery
Title of the study (Brief title) pathogenic bacteria of acute endopthalmitis after cataract surgery
Region
Japan

Condition
Condition acute endopthalmitis after cataract surgery
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate pathogenic bacteria and surgical outcome of vitrectomy for acute endopthalmitis after catract surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mean visual activities in logarithmic minimum angle of resolution between 17 eyes in 17 patients(group A) who underwent a vitrectomy from April 2008 to December 2015 and 53 eyes in 52 patients from June 1992 to March 2006.
Key secondary outcomes

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 endopthalmitis after cataract surgery
Key exclusion criteria endopthalmitis after cataract surgery which occured 6 weeks after cataract surgery

Cases which necessary information for examination could not be obtained

Target sample size 70

Research contact person
Name of lead principal investigator Inoue Makoto
Organization Kyorin University School of Medicine
Division name Department of Opthaimology
Address Kyorin University School of Medicine 6-20-2 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 Opthaimology
Address Kyorin University School of Medicine 6-20-2 Shinkawa,Mitaka,Tokyo,Japan
TEL 0422-47-5511
Homepage URL
Email mochizuki@eye-center.org

Sponsor
Institute Kyorin University
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 02 Month 06 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 24 Day
Anticipated trial start date
2017 Year 02 Month 02 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 Published
URL releasing results
Results
Other related information We presented point of this consideration at The 55th Annual Meeting of Japanese Retina and Vitreous Society.

Management information
Registered date
2017 Year 02 Month 02 Day
Last modified on
2017 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029793