UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053497 |
|---|---|
| Receipt number | R000061006 |
| Scientific Title | Clinical study for regulatory approval of new medical device "Image diagnosis support program for eye observation" |
| Date of disclosure of the study information | 2024/02/29 |
| Last modified on | 2024/01/31 16:47:52 |
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Basic information
Public title
Clinical study for regulatory approval of new medical device "Image diagnosis support program for eye observation"
Acronym
Clinical study for regulatory approval of new medical device "Image diagnosis support program for eye observation"
Scientific Title
Clinical study for regulatory approval of new medical device "Image diagnosis support program for eye observation"
Scientific Title:Acronym
Clinical study for regulatory approval of new medical device "Image diagnosis support program for eye observation"
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the performance of an image diagnosis support program for eye observation and clarify its usefulness.
Basic objectives2
Others
Basic objectives -Others
Verification of non-inferiority of the diagnosis results of this program against the diagnosis results of ophthalmologists.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
"Sensitivity", "specificity", and "AUC" of the diagnosis results of this program when the diagnosis by an ophthalmologist is considered as the correct answer in the evaluation dataset.
In the evaluation data set, when the ophthalmologist's diagnosis is considered the correct answer, whether or not the ophthalmologist's diagnosis result and the diagnosis result of this program are non-inferior.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among the cases of "Approval number: 20200283 Ophthalmological image analysis using artificial intelligence", cases with nuclear sclerosis cataract (including cases with other ophthalmological diseases) among those who have consented to permission for secondary use.
Among the above cases, cases in which anterior segment images were taken using a slit lamp microscope as part of routine medical treatment.
Key exclusion criteria
Cases that refused to participate in the study
Cases used in the development of the verification algorithm (research by the Minami Aoyama Eye Clinic Ethics Review Committee (202101)) (learning dataset for the algorithm scheduled to be verified in this research)
Other cases judged to be inappropriate by the primary investigator or sub-investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuno |
| Middle name | |
| Last name | Negishi |
Organization
Keio University School of medicine
Division name
Department of Ophthalmology
Zip code
160-0016
Address
35 Shinanomachi Shinjuku Tokyo Japan
TEL
03-3353-0149
kazunonegishi@keio.jp
Public contact
Name of contact person
| 1st name | Masatoshi |
| Middle name | |
| Last name | Hirayama |
Organization
Keio University schooKeio University school of medicine
Division name
Department of Ophthalmology
Zip code
160-0016
Address
35 Shinanomachi Shinjuku Tokyo Japan
TEL
03-5363-3821
Homepage URL
mar_hirayama@keio.jp
Sponsor or person
Institute
Department of Ophthalmology, Keio University
Institute
Department
Personal name
Funding Source
Organization
AMED
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 shool of medicine Institutional Review Board
Address
35 Shinanomachi Shinjuku Tokyo Japan
Tel
03-3353-1211
xxx@xxx
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 | 02 | Month | 29 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the sensitivity, specificity, and AUC of programmed medical devices using acquired image data
Management information
Registered date
| 2024 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
