UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055679 |
|---|---|
| Receipt number | R000063622 |
| Scientific Title | Development of an Educational Method Based on Artificially Generated Images: Diagnosis of Corneal Diseases and Eyelid Tumor |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/09/30 15:05:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of an AI-Generated Image Training Method for Ophthalmic Disease Diagnosis
Acronym
AIGIDEM (Artificially Generated Image Diagnosis Education Method)
Scientific Title
Development of an Educational Method Based on Artificially Generated Images: Diagnosis of Corneal Diseases and Eyelid Tumor
Scientific Title:Acronym
AIGIDEM (Artificially Generated Image Diagnosis Education Method)
Region
| Japan |
Condition
Condition
Corneal Diseases,Eyelid Tumors
Classification by specialty
| Ophthalmology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether synthetic images of corneal diseases and eyelid tumors generated using an artificial intelligence method called "Stable Diffusion" can enhance the learning effect in image-based diagnosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Accuracy: Evaluate the change in overall accuracy of general ophthalmologists and trainees in diagnosing corneal diseases and eyelid tumors before and after the training, and compare the results with the accuracy of specialists.
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
| 24 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A total of 10 to 20 general ophthalmologists who do not specialize in corneal or eyelid conditions, as well as ophthalmology trainees. Additionally, 2 or more specialists in corneal diseases and eyelid tumors will be included as controls.
Key exclusion criteria
1.Specialists: Corneal and eyelid specialists will be excluded from the training group.
2.Refusal of Participation: Participants who cannot provide informed consent for research participation will be excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tabuchi |
| Middle name | |
| Last name | Hitoshi |
Organization
Tsukazaki Hospital
Division name
Ophthalmology
Zip code
671-1227
Address
68-1 Aboshi Waku, Himeji, Hyogo, Japan
TEL
079-272-8555
h.tabuchi@tsukazaki-eye.net
Public contact
Name of contact person
| 1st name | Tabuchi |
| Middle name | |
| Last name | Hitoshi |
Organization
Tsukazaki Hospital
Division name
Ophthalmology
Zip code
671-1227
Address
68-1 Aboshi Waku, Himeji, Hyogo, Japan
TEL
079-272-8555
Homepage URL
h.tabuchi@tsukazaki-eye.net
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Self-Funding
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
Tsukazaki Hospital
Address
68-1 Aboshi Waku, Himeji, Hyogo, Japan
Tel
079-272-8555
h.tabuchi@tsukazaki-eye.net
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 | 11 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063622
