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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026489
Receipt No. R000024392
Scientific Title The prospective study searching for the frequency of the endophthalmitis without antibiotic eye drop before and after a intravitreal injection to the macular diseases.
Date of disclosure of the study information 2017/03/10
Last modified on 2018/01/18

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Basic information
Public title The prospective study searching for the frequency of the endophthalmitis without antibiotic eye drop before and after a intravitreal injection to the macular diseases.
Acronym The frequency of the endophthalmitis without antibiotic eye drop before and after a intravitreal injection
Scientific Title The prospective study searching for the frequency of the endophthalmitis without antibiotic eye drop before and after a intravitreal injection to the macular diseases.
Scientific Title:Acronym The frequency of the endophthalmitis without antibiotic eye drop before and after a intravitreal injection
Region
Japan

Condition
Condition Macular diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To know when washing and sterilizing bacteria in the ocular surface with povidone iodine during an injection, it does not need before and after antibiotic eye drop for intravitreal injection.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The frequency of endophthalmitis 1 month after intravitreal injection
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravitreal injections without antibacterial medicine
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients of age-related macular degeneration, retinal vein occulusion, diabetic macular edema and myopic choroidal neovascularization who need intravitreal injection of anti-VEGF.
Key exclusion criteria Compromised patient and have a allergy for povidone iodine
Target sample size 15500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Shimada
Organization Nihon university hospital
Division name Ophthalmology
Zip code
Address 1-6 Kandasurugadai Chiyoda-ku Tokyo Japan
TEL 0332931711
Email shimada.hiroyuki@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Tanaka
Organization Nihon university hospital
Division name Ophthalmology
Zip code
Address 1-6 Kandasurugadai Chiyoda-ku Tokyo Japan
TEL 0332931711
Homepage URL
Email tanaka.koji@nihon-u.ac.jp

Sponsor
Institute Nihon 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)

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 日本大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 10 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 Completed
Date of protocol fixation
2015 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 10 Day
Last modified on
2018 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024392

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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