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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002841
Receipt No. R000003463
Scientific Title Measurement of macular retinal nerve fiber layer thickness using spectral domain optical coherence tomography
Date of disclosure of the study information 2009/12/03
Last modified on 2009/12/03

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Basic information
Public title Measurement of macular retinal nerve fiber layer thickness using spectral domain optical coherence tomography
Acronym Measurement of macular retinal nerve fiber layer thickness using SD-OCT
Scientific Title Measurement of macular retinal nerve fiber layer thickness using spectral domain optical coherence tomography
Scientific Title:Acronym Measurement of macular retinal nerve fiber layer thickness using SD-OCT
Region
Japan

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

Objectives
Narrative objectives1 change (thinning) of macular retinal nerve fiber thickness in glaucoma patient
Basic objectives2 Others
Basic objectives -Others change (thinning) of macular retinal nerve fiber thickness in glaucoma patient
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes macular retinal nerve fiber thickness at various stage of glaucoma
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria agreement for this measurement
Key exclusion criteria complications with other macular diseases
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiya Takamatsu
Organization Hiroshima University
Division name Department of Ophthalmology and Visual Science
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima, JAPAN
TEL 082-257-5247
Email

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

Sponsor
Institute Hiroshima University
Department of Ophthalmology and Visual Science
Institute
Department

Funding Source
Organization None
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
2009 Year 12 Month 03 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 Enrolling by invitation
Date of protocol fixation
2009 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 12 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 correlation with stage of glaucoma (loss of visual field, visual acuity) and macular retinal nerve fiber thickness
retrospective
sampling for case control

Management information
Registered date
2009 Year 12 Month 03 Day
Last modified on
2009 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003463

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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