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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004821
Receipt No. R000005739
Scientific Title Observation study on measurement macular pigment optical density using resonance raman spectroscopy
Date of disclosure of the study information 2011/01/05
Last modified on 2012/05/21

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Basic information
Public title Observation study on measurement macular pigment optical density
using resonance raman spectroscopy
Acronym Measurement macular pigment optical density using resonance raman spectroscopy
Scientific Title Observation study on measurement macular pigment optical density
using resonance raman spectroscopy
Scientific Title:Acronym Measurement macular pigment optical density using resonance raman spectroscopy
Region
Japan

Condition
Condition age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate macular pigment density in patients with age-related macular degeneration
Basic objectives2 Others
Basic objectives -Others Observation study
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Macular pigment optical density
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

Not applicable
Gender Male and Female
Key inclusion criteria (1)Eyes with age-related macular degeneration

(2)Judged by the investigator to be eligible as a subject on the basis of screening tests

(3)Aged 50 years or older at provision of informed consent, and has given consent in writing
Key exclusion criteria (1)Presence of cataracts of a severity sufficient
(2)Pupile size of less than 6.5 mm
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Obana
Organization Seirei Hamamatsu General Hospital
Division name Department of Ophthalmology
Zip code
Address 2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, 430-8558, Japan
TEL 053-474-2222
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name Department of Ophthalmology
Zip code
Address 2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, 430-8558, Japan
TEL 053-474-2222
Homepage URL
Email

Sponsor
Institute Seirei Hamamatsu Genaral Hospital (Shizuoka Prefecture)
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japan Ocular Carotenoids Study Group(JOCS)
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 北海道大学大学院医学研究科医学専攻研究眼科学講座(北海道)、聖隷浜松病院眼科(静岡県)、神戸大学医学部眼科(兵庫県)、島根大学医学部眼科(島根県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 05 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
2010 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observation study

Management information
Registered date
2011 Year 01 Month 05 Day
Last modified on
2012 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005739

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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