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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005217
Receipt No. R000006166
Scientific Title Clinical study for progression of glaucomatous peripheral disturbance based on OCT
Date of disclosure of the study information 2011/04/01
Last modified on 2011/03/08

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Basic information
Public title Clinical study for progression of glaucomatous peripheral disturbance based on OCT
Acronym Glaucomatous peripheral disturbance based on OCT
Scientific Title Clinical study for progression of glaucomatous peripheral disturbance based on OCT
Scientific Title:Acronym Glaucomatous peripheral disturbance based on OCT
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether OCT is more available for the detection of the progression of peripheral disturbance than periphemetry measurement
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes RNFL and MD
Key secondary outcomes IOP

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
80 years-old >=
Gender Male and Female
Key inclusion criteria Glaucoma patients
Key exclusion criteria 1)Progressed glaucoma
2)Cataract
3)pregnacy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Kiuchi
Organization Hiroshima University
Division name Ophthalmology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5247
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hiroshima University
Division name Ophthalmology
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology, Hiroshima Univ.
Institute
Department

Funding Source
Organization Department of Ophthalmology, Hiroshima Univ.
Organization
Division
Category of Funding 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

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 01 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
2009 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 09 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 Evaluation for the relation ship between change of RNFL and visual field disturbance.

Management information
Registered date
2011 Year 03 Month 08 Day
Last modified on
2011 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006166

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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