UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002841 |
|---|---|
| Receipt number | 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 16:27:13 |
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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
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
Sponsor or person
Institute
Hiroshima University
Department of Ophthalmology and Visual Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003463
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
