UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004821 |
|---|---|
| Receipt number | 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 | 2021/04/13 17:06:42 |
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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 | Akira |
| Middle name | |
| Last name | Obana |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Ophthalmology
Zip code
430-8558
Address
Naka-ku
TEL
0534742222
obana@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Asano |
Organization
Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name
Department of Ophthalmology
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, 430-8558, Japan
TEL
053-474-2222
Homepage URL
asanoma@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu Genaral Hospital (Shizuoka Prefecture)
Institute
Department
Personal name
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
Seirei Hamamatsu General Hospital
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City
Tel
0534742222
asanoma@sis.seirei.or.jp
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
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
37
Results
The Raman counts of the patients with age-related macular degeneration ranged from 737 to 3288. the mean was 2056, standard deviation was 973.
Results date posted
| 2021 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients with exudative age-related macular degeneration
Participant flow
Macular pigment optical density was measuered.
Adverse events
None
Outcome measures
Macular pigment optical density
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2010 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2010 | Year | 02 | Month | 17 | Day |
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
| 2021 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005739
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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