UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059337 |
|---|---|
| Receipt number | R000067869 |
| Scientific Title | Real-world field studies aimed at implementing future ophthalmological examinations in society |
| Date of disclosure of the study information | 2025/10/09 |
| Last modified on | 2025/10/08 14:21:44 |
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Basic information
Public title
Real-world field studies aimed at implementing future ophthalmological examinations in society
Acronym
Real-world field studies aimed at implementing future ophthalmological examinations in society
Scientific Title
Real-world field studies aimed at implementing future ophthalmological examinations in society
Scientific Title:Acronym
Real-world field studies aimed at implementing future ophthalmological examinations in society
Region
| Japan |
Condition
Condition
Individuals who underwent a medical examination at the Sendai Open Hospital Health Checkup Center and provided their consent to participate in the research
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study targets individuals undergoing health checkups. It aims to establish a system for predicting the risk of developing eye diseases and systemic diseases, as well as for early detection of potential onset, by introducing OCT examinations during health checkups and a remote fundus imaging interpretation system at an interpretation center. The study will verify prediction and detection methods and explore effective mechanisms.
Basic objectives2
Others
Basic objectives -Others
We have researched and developed AI-powered algorithms for disease screening and risk assessment using fundus imaging data. This study integrates these algorithms into a remote health screening system to validate a future-oriented screening platform in real-world settings. This platform facilitates the transmission of screening results and the optimization (tuning) of AI algorithms using screening data.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of System Functionality and Accuracy
AI-predicted risks of atherosclerotic diseases and glaucoma from fundus and nailfold images, along with disease screening results, and their consistency with the presence of abnormal findings and Grade assessments during health examinations (cross-sectional evaluation)
Key secondary outcomes
Consistency between AI-predicted risks of atherosclerotic disease and glaucoma from fundus images and the actual incidence rates of these conditions within 10 years after image acquisition (longitudinal evaluation using historical data)
Percentage of image and other data meeting quality standards required for analysis
Evaluation of the correlation between disease risk and disease occurrence and the results of parameters calculated from background information (age, gender, medical history, etc.), health checkup results (blood tests, etc.), parameters calculated from fundus images and OCT examinations (vascular density, nerve thickness, etc.), ophthalmic findings (visual acuity, intraocular pressure, etc.), and parameters calculated from nail bed examination image evaluations
Evaluation of improvements in accuracy after updating fine-tuning training data and post-annotation
Functional verification of each system and assessment of system errors, malfunctions, and risk occurrence
Investigation of task processing times
Value Assessment of Future-Oriented Health Checkups: Concept, Platform, and System Evaluation
Confirmation of Implementation Structure: Identifying and Improving Issues in Structure, Workflow, and Operations
Task Processing Time Survey
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who visited the Sendai Open Hospital Health Checkup Center and provided their consent to participate in the research
(18 years of age or older)
Key exclusion criteria
(1) Individuals who cannot provide informed consent
(2) Patients with a history of photosensitivity
(3) Patients who have recently undergone photodynamic therapy (PDT) (Refer to the package insert of the administered photosensitizer for the prohibited period.)
(4) Patients currently taking medications with photosensitivity as a potential side effect
(5) Individuals with epilepsy
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Yokoyama |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi , Japan
TEL
022-717-7294
yu.yokoyama.c4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Yokoyama |
Organization
Tohoku University Hospital
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai , Miyagi , Japan
TEL
022-717-7294
Homepage URL
yu.yokoyama.c4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
TOPCON CORPORATION
The Dai-ichi Life Insurance Company, Limited
Name of secondary funder(s)
TOPCON CORPORATION
The Dai-ichi Life Insurance Company, Limited
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
ec-med@grp.tohoku.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
東北大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 09 | 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
| 2025 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study targets individuals undergoing health checkups. It aims to establish a system for predicting the risk of developing eye diseases and systemic diseases, as well as for early detection of potential onset, through the introduction of OCT examinations during health checkups and a remote fundus imaging interpretation system at an interpretation center. The study will verify prediction and detection methods and explore effective mechanisms.
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067869
