UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048669 |
|---|---|
| Receipt number | R000055449 |
| Scientific Title | Development of an application to record macular disease symptoms |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2022/08/15 16:49:48 |
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Basic information
Public title
Development of an application to record macular disease symptoms
Acronym
Development of an application to record macular disease symptoms
Scientific Title
Development of an application to record macular disease symptoms
Scientific Title:Acronym
Development of an application to record macular disease symptoms
Region
| Japan |
Condition
Condition
macular disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the feasibility of using an iPhone-mounted research application for recording of metamorphosis, central dark spots, etc.
Basic objectives2
Others
Basic objectives -Others
not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of metamorphopsis, central dark spot
Key secondary outcomes
Age, Sex, Ophthalmologic history
(Profiling by comparing test results by age, sex, ophthalmologic history, etc.)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Examination to detect metamorphosis, central dark spot, etc.
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
Japanese who downloaded research application published on "TestFlight" or "Research Kit", a framework for medical research provided by Apple Inc.
Key exclusion criteria
No exclusion criteria
Target sample size
5600
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Miyake |
Organization
Kyoto University Graduate School of Medicine
Division name
Ophthalmology & Visual Sciences
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3250
miyakem@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Miyake |
Organization
Kyoto University Graduate School of Medicine
Division name
Ophthalmology & Visual Sciences
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3250
Homepage URL
miyakem@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine,Department of Ophthalmology & Visual Sciences
Institute
Department
Personal name
Funding Source
Organization
FINDEX Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2022 | Year | 09 | 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 | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 15 | Day |
Last modified on
| 2022 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055449
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
