UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054826 |
|---|---|
| Receipt number | R000062647 |
| Scientific Title | Investigation of the association between vitreoretinal diseases and lifestyle-related conditions, including their complications and comorbidities, using big data |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/06/29 22:37:17 |
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Basic information
Public title
Investigation of the association between vitreoretinal diseases and lifestyle-related conditions, including their complications and comorbidities, using big data
Acronym
Investigation of the association between vitreoretinal diseases and lifestyle-related conditions, including their complications and comorbidities, using big data
Scientific Title
Investigation of the association between vitreoretinal diseases and lifestyle-related conditions, including their complications and comorbidities, using big data
Scientific Title:Acronym
Big data and vitreoretinal diseases
Region
| Japan |
Condition
Condition
Vitreoretinal diseases
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify the risk factors for the onset of vitreoretinal diseases and the factors involved in their progression, to deepen the understanding of the mechanisms of disease onset and progression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigate the association between the history of systemic medication use, other comorbidities, and the onset and progression of vitreoretinal diseases using multivariate analysis.
Key secondary outcomes
Preventive effects of treatments for non-ocular diseases on the onset and progression of vitreoretinal diseases.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with eye diseases who have a history of visiting an ophthalmology clinic
Key exclusion criteria
Patients with less than 6 months of hospital visits
Target sample size
70000
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Kurihara |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-121
kurihara@z8.keio.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Tomita |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-121
Homepage URL
y.tomita@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Donations from philanthropists
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
Institutional Review Board of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 JAPAN
Tel
03-5363-3879
med-rinri-jimu@adst.keio.ac.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
| 2024 | Year | 07 | 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
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is a database research using big data.
Management information
Registered date
| 2024 | Year | 06 | Month | 29 | Day |
Last modified on
| 2024 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062647
