UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048539 |
|---|---|
| Receipt number | R000055147 |
| Scientific Title | High-risk eyeball morphology for age-related macular degeneration |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2023/01/31 12:57:17 |
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Basic information
Public title
High-risk eyeball morphology for age-related macular degeneration
Acronym
HEMA study
Scientific Title
High-risk eyeball morphology for age-related macular degeneration
Scientific Title:Acronym
HEMA study
Region
| Japan |
Condition
Condition
Age-Related Macular Degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
I analyze structure of vitreous body - retina - choroid membrane by the Axial Length and the progress degree of the aging-related change and them and the relations with the onset risk, the progress risk of AMD.
Basic objectives2
Others
Basic objectives -Others
I connect it with a presence and progress degree of eyes axis length and AMD and analyze a vitreous aging-related liquefaction change, the volume of the retina nervous system, thickness of RPE, a change of the choroidal vasculature.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
I examine progress of AMD and the anatomical features of the others eyeball in addition.
OCTA
Key secondary outcomes
2 values process a provided image using software and see a range of AMD and the relationship of the parameter. In addition, I compare it with the physically unimpaired person.
Optos, SS-OCT, SD-OCT
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
It applies to all patients who came to the hospital for a medical examination with macula disease.
Key exclusion criteria
The patient that the agreement for this study is not provided takes it off from an object.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | MInami |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3879
S.Minami@keio.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Minami |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3879
Homepage URL
S.Minami@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
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, Shinjuku-ku, Tokyo
Tel
03-5363-3879
S.Minami@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
| 2022 | Year | 08 | Month | 01 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
I grasp the condition of a patient of AMD more precisely.
Management information
Registered date
| 2022 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055147
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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