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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004002
Receipt No. R000004814
Scientific Title Evaluation of trabeculotomy using two iStents
Date of disclosure of the study information 2010/08/05
Last modified on 2012/02/15

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Basic information
Public title Evaluation of trabeculotomy using two iStents
Acronym Evaluation of trabeculotomy using two iStents
Scientific Title Evaluation of trabeculotomy using two iStents
Scientific Title:Acronym Evaluation of trabeculotomy using two iStents
Region
Japan

Condition
Condition glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evalucate intraocular pressure lowering effect and safty
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intraocular pressure, safty
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
Device,equipment
Interventions/Control_1 trabeculotomy with 2 iStents
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 open angle glaucoma
Key exclusion criteria previous intraocular surgery except cataract surgery.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Shiba
Organization Keio university
Division name Ophthalmology
Zip code
Address 35 shinanomachi, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University
Division name Ophthalmlogy
Zip code
Address 35 shinanomachi, Shinjuku-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Ophthalmology, Keio University
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

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 05 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 05 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 05 Day
Last modified on
2012 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004814

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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