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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005114
Receipt No. 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

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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
Email

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
Email fgomi@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Osaka University graduate school of medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006081

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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