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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048539
Receipt No. 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 2022/08/01

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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
Email 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
Email S.Minami@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email 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 Preinitiation
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
2022 Year 08 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055147

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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