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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031745
Receipt No. R000036244
Scientific Title A retrospective observational study on the evaluation of Trabectome by aqueous humor outflow
Date of disclosure of the study information 2018/03/16
Last modified on 2018/03/15

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Basic information
Public title A retrospective observational study on the evaluation of Trabectome by aqueous humor outflow
Acronym A retrospective study on the evaluation of Trabectome by aqueous flow
Scientific Title A retrospective observational study on the evaluation of Trabectome by aqueous humor outflow
Scientific Title:Acronym A retrospective study on the evaluation of Trabectome by aqueous flow
Region
Japan

Condition
Condition Primary open angle glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the effectiveness of Trabectome
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Aqueous humor outflow
Intraocural pressure
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 primary open-angle glaucoma
Key exclusion criteria pterygium, pinguecula or any condition which might interfere with the observation of aqueous humor flow in the eye.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshihiko Ueda
Organization Nihonmatsu Eye Hospital
Division name ophthalmology
Zip code
Address 4-10-7 Hirai Edogawa-ku,Tokyo, Japan
TEL 03-3681-1257
Email ueda@nihonmatsu.net

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Ueda
Organization Nihonmatsu Eye Hospital
Division name ophthalmology
Zip code
Address 4-10-7 Hirai Edogawa-ku,Tokyo, Japan
TEL 03-3681-1257
Homepage URL
Email ueda@nihonmatsu.net

Sponsor
Institute Nihonmatsu Eye Hospital
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
2018 Year 03 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information There was a significant correlation between an increase in the composite AHO score and a decrease in IOP after trabectome.

Management information
Registered date
2018 Year 03 Month 15 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036244

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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