UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018746 |
|---|---|
| Receipt number | R000021686 |
| Scientific Title | Evaluation of peripheral fundus autofluorescence in eyes with wet age-related macular degeneration |
| Date of disclosure of the study information | 2015/08/20 |
| Last modified on | 2015/08/22 00:14:34 |
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Basic information
Public title
Evaluation of peripheral fundus autofluorescence in eyes with
wet age-related macular degeneration
Acronym
Evaluation of Peripheral Fundus Autofluorescence in wet AMD
Scientific Title
Evaluation of peripheral fundus autofluorescence in eyes with
wet age-related macular degeneration
Scientific Title:Acronym
Evaluation of Peripheral Fundus Autofluorescence in wet AMD
Region
| Japan |
Condition
Condition
wet age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate prevalence of abnormal peripheral fundus autofluorescence (FAF) in eyes with wet age-related macular degeneration (AMD) using wide field scanning laser ophthalmoscope, Optos200Tx.
Basic objectives2
Others
Basic objectives -Others
To characterize the frequencies of abnormal peripheral FAF patterns in the eyes of Japanese AMD patients in regards to AMD disease types, treatments, and locations.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
prevalence of abnormal peripheral fundus autofluorescence
Key secondary outcomes
the relative risk analyses of abnormal peripheral fundus autofluorescence by disease types and treatments.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who diagnosed wet AMD
Key exclusion criteria
Patients who diagnosed central serous chorioretinopathy CSC or any other vitreo-retinal diseases.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Ogura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
052-853-8251
ogura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aki Kato |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
052-853-8251
Homepage URL
akikato@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Science
Nagoya City University Graduate School of Medical Sciences
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
none
Name of secondary funder(s)
none
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
| 2015 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Wide field FAF were obtained from the patiens who visited Nagoya City University Hospital between March 2012 and October 2014 and diagnosed as wet AMD, cataract or normal eyes without any diagnosed abnormalities.
Wide field FAF images were collected and analyzed retrosptectively .
Management information
Registered date
| 2015 | Year | 08 | Month | 20 | Day |
Last modified on
| 2015 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021686
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
