UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026489 |
|---|---|
| Receipt number | 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 18:53:25 |
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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
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
tanaka.koji@nihon-u.ac.jp
Sponsor or person
Institute
Nihon 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024392
