UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025978
Receipt number R000029793
Scientific Title 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 21:05:27

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Basic information

Public title

transition of surgical outcome in eyes underwent vitrectomy for acute endopthalmitis after cataract surgery

Acronym

pathogenic bacteria of acute endopthalmitis after cataract surgery

Scientific Title

transition of surgical outcome in eyes underwent vitrectomy for acute endopthalmitis after cataract surgery

Scientific Title:Acronym

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

1st name
Middle name
Last name Inoue Makoto

Organization

Kyorin University School of Medicine

Division name

Department of Opthaimology

Zip code


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

1st name
Middle name
Last name Tsukasa Mochizuki

Organization

Kyorin University School of Medicine

Division name

Department of Opthaimology

Zip code


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 or person

Institute

Kyorin University

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 02 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2016 Year 07 Month 24 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029793


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name