UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019924 |
|---|---|
| Receipt number | R000023001 |
| Scientific Title | Association of macular pigment optical density and eye condition |
| Date of disclosure of the study information | 2015/11/25 |
| Last modified on | 2020/04/25 05:51:43 |
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Basic information
Public title
Association of macular pigment optical density and eye condition
Acronym
MPOD and eye codition
Scientific Title
Association of macular pigment optical density and eye condition
Scientific Title:Acronym
MPOD and eye codition
Region
| Japan |
Condition
Condition
patients with eye diseases and healthy cases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association of MPOD, visual function, eye and systemic condition
Basic objectives2
Others
Basic objectives -Others
cross-sectional
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MPOD, visual function, eye exam and blood exam
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with eye diseases and healthy cases
Key exclusion criteria
Those who cannot undergo the examinations
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
Keio University
Division name
Department of Ophthalmology, School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL
03-3353-1211
ozawa@a5.keio.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Ozawa |
Organization
Keio University
Division name
Department of Ophthalmology, School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
ozawa@a5.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi Shinjukuku Tokyo
Tel
0333531211
ozawa@a5.keio.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 25 | 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
| 2015 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Case control study. Patients who visited Keio University Hospital after the registration starting date or healthy volunteears, who agreed to join the study are included. They receive MPOD, visual function, eye and blood exams.
Management information
Registered date
| 2015 | Year | 11 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023001
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
