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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017094
Receipt No. R000019825
Scientific Title Prospective cohort study of 360-degree suture trabeculotomy
Date of disclosure of the study information 2015/04/10
Last modified on 2018/12/26

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Basic information
Public title Prospective cohort study of 360-degree suture trabeculotomy
Acronym Prospective cohort study of 360-degree suture trabeculotomy
Scientific Title Prospective cohort study of 360-degree suture trabeculotomy
Scientific Title:Acronym Prospective cohort study of 360-degree suture trabeculotomy
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safty and efficacy of the surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraocular pressure, complication
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 360-degree suture trabeculotomy ab externo
Interventions/Control_2 360-degree suture trabeculotomy ab interno
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 Intent to treat by the surgery
Key exclusion criteria none
Target sample size 120

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Daisuke Shiba
Organization Keio university school of medicine
Division name Department of ophthalmolgoy
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email shibadaisuke@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Daisuke Shiba
Organization Keio university school of medicine
Division name Department of ophthalmology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email shibadaisuke@gmail.com

Sponsor
Institute Department of ophthalmology, Keio university school of medicine
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 04 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 Open public recruiting
Date of protocol fixation
2015 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 10 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019825

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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