UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057008 |
|---|---|
| Receipt number | R000065085 |
| Scientific Title | Creating AI to predict diagnosis and treatment of ophthalmic diseases |
| Date of disclosure of the study information | 2025/02/12 |
| Last modified on | 2025/02/12 20:48:08 |
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Basic information
Public title
Creating AI to predict diagnosis and treatment of ophthalmic diseases
Acronym
Creating AI to predict diagnosis and treatment of ophthalmic diseases
Scientific Title
Creating AI to predict diagnosis and treatment of ophthalmic diseases
Scientific Title:Acronym
Creating AI to predict diagnosis and treatment of ophthalmic diseases
Region
| Japan |
Condition
Condition
orbital disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research aims to efficiently utilize clinical information recorded in electronic medical records of patients with ophthalmologic diseases. Specifically, the primary objective is to develop an artificial intelligence (AI) system that automatically extracts clinical information from electronic medical record information, including image data from head CT and MRI examinations. Furthermore, the second objective is to develop an AI system that predicts the diagnosis and optimal treatment of ophthalmic diseases based on the extracted clinical information. Through this system, we aim to contribute to the improvement of the quality of medical care by efficiently analyzing the enormous amount of electronic medical record data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement between ophthalmologist's judgment and AI's judgment
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
The subjects must have been diagnosed with ophthalmologic diseases at the outpatient clinic of Kyoto Prefectural University Hospital between January 1, 2010 and June 30, 2028, the end of the study period.
Key exclusion criteria
Patients or surrogates who have indicated that they will not participate in this study
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Okumura |
Organization
Doshisha University
Division name
Department of Biomedical Engineering
Zip code
610-0394
Address
1-3 tatara Mlyakodani, Kyotanabe, Japan
TEL
0774-65-6508
nokumura@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Okumura |
Organization
Doshisha University
Division name
Department of Biomedical Engineering
Zip code
610-0394
Address
1-3 tatara Mlyakodani, Kyotanabe, Japan
TEL
0774-65-6508
Homepage URL
nokumura@mail.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
Funding Source
Organization
Doshisha University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Doshisha University
Address
1-3 tatara Mlyakodani, Kyotanabe, Japan
Tel
075-251-3158
ji-oer@mail.doshisha.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
| 2025 | Year | 02 | Month | 12 | 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
666
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Retrospective observational study
Method of recruitment of subjects: All patients with ophthalmologic diseases who visited Kyoto Prefectural University of Medicine on or after January 1, 2010
Management information
Registered date
| 2025 | Year | 02 | Month | 12 | Day |
Last modified on
| 2025 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065085
