UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005114 |
|---|---|
| Receipt number | R000006081 |
| Scientific Title | Assessment of the necessity of eye draping for intravitreal injection under the use of the disposable eye speculum |
| Date of disclosure of the study information | 2011/02/28 |
| Last modified on | 2012/02/21 09:11:00 |
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Basic information
Public title
Assessment of the necessity of eye draping for intravitreal injection under the use of the disposable eye speculum
Acronym
Eye Speculum study
Scientific Title
Assessment of the necessity of eye draping for intravitreal injection under the use of the disposable eye speculum
Scientific Title:Acronym
Eye Speculum study
Region
| Japan |
Condition
Condition
Exudative age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the bacterial isolation rate in the conjunctiva with or without draping at the intravitreal injection under the use of disporsable eye speculum (EzSpec).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
comparison of bacterial isolation rate between the groups with- and without-draping
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Intravitreal injection with draping
Interventions/Control_2
Intravitreal injection without draping
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subject who has exudative AMD and be scheduled intravitreal injection of Ranibizumab or Pegaptanib for the first time.
Key exclusion criteria
1)Immunocompromised status
2)Difficulty to have intravitreal injection
3)Case who was judged inapropriate for examination object (progressing glaucoma etc.)
4)Atopic dermatitis
5)Hypersensitivity against antiseptic substance
6)Treated with antimicrobial agent not for intravitreal injection two weeks before the first injection.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumi Gomi |
Organization
Osaka university graduate school of medicine
Division name
Department of Ophthalmology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University graduate school of medicine
Division name
Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
fgomi@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Osaka University graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
HOYA Corporation Medical Division
Organization
Division
Category of Funding Organization
Profit organization
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
愛媛大学医学部附属病院(愛媛県）、大阪大学医学部附属病院（大阪府）、香川大学医学部附属病院（香川県）、鹿児島大学医学部附属病院（鹿児島）、九州大学医学部附属病院（福岡県）、杏林大学医学部附属病院（東京都）、滋賀医科大学医学部附属病院（滋賀県）、東京大学医学部附属病院（東京都）、東邦大学医学部附属佐倉病院（千葉県）、名古屋大学医学部附属病院（愛知県）、日本大学医学部附属駿河台病院（東京都）、福島県立医大附属病院（福島県）、横浜市大医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 28 | 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
| 2010 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 21 | Day |
Last modified on
| 2012 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006081
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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