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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009625
Receipt No. R000011157
Scientific Title Investigation of geographic atrophy for eye disease patient
Date of disclosure of the study information 2012/12/28
Last modified on 2013/06/25

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Basic information
Public title Investigation of geographic atrophy for eye disease patient
Acronym Investigation of geographic atrophy
Scientific Title Investigation of geographic atrophy for eye disease patient
Scientific Title:Acronym Investigation of geographic atrophy
Region
Japan

Condition
Condition 1.Typical age-related macular degenration
2.Polypoidal choroidal vasculopathy
3.Retinal angiomatous proliferation
4.Central serous chorioretinopathy
5.Idiopathic macular telangiectasia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We purposed using new image analysis software for semiautomated quantification of atrophic areas in eyes with geographic atrophy (GA) on images obtained by confocal scanning laser ophthalmoscopy FAF (fundus autofluorescence) imaging. And, we investigated an incidence of GA, and the enlargemrnt rate of GA over time in eye disease patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fundus autofluorescence
Color fundus phtograph
Visual acuity
Optical coherence tomography
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
50 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria The patient correspond to subject eye disoeder.
Key exclusion criteria The patient not correspond to subject eye disoeder.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Fujiwara
Organization Kagawa university
Division name Department of Ophthalmology
Zip code
Address 1750-1, Ikenobe, Miki-cho, Kita-gun
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Fujiwara
Organization Kagawa university
Division name Department of Ophthalmology
Zip code
Address 1750-1, Ikenobe, Miki-cho, Kita-gun
TEL
Homepage URL
Email

Sponsor
Institute Kagawa University
Institute
Department

Funding Source
Organization Kagawa University
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
2012 Year 12 Month 28 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 Completed
Date of protocol fixation
2012 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2012 Year 12 Month 25 Day
Last modified on
2013 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011157

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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