UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059264 |
|---|---|
| Receipt number | R000067197 |
| Scientific Title | Data collection study on a fundus diagnosis support program using a portable fundus camera |
| Date of disclosure of the study information | 2025/10/02 |
| Last modified on | 2025/10/02 10:28:57 |
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Basic information
Public title
Data collection study on a fundus diagnosis support program using a portable fundus camera
Acronym
Data collection study on a fundus diagnosis support program using a portable fundus camera
Scientific Title
Data collection study on a fundus diagnosis support program using a portable fundus camera
Scientific Title:Acronym
Data collection study on a fundus diagnosis support program using a portable fundus camera
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study utilizes a handheld fundus camera for healthcare professionals to observe the fundus, collect images, and gather clinical information. This enables observation of fundus morphology differences associated with glaucoma presence and collects training and validation data (images and clinical information) for future development of an AI program supporting glaucoma diagnosis.
Basic objectives2
Others
Basic objectives -Others
Data collection research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Not applicable (for data collection research)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 18 or older at the time of consent acquisition (gender not specified)
2. Patients for whom written informed consent regarding participation in this study can be obtained
3. Patients deemed by a physician to be suitable candidates for examination of retinal diseases
3. Patients for whom a physician deems examination for retinal disease desirable
Key exclusion criteria
1. Patients determined by the principal investigator or co-investigator to be clearly at undue disadvantage by participating in the study
2. Patients determined by the principal investigator or co-investigator to clearly impede the conduct or evaluation of this clinical research by participating in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sakaguchi |
| Middle name | |
| Last name | Hirokazu |
Organization
Hiroshima University Hospital
Division name
Ophthalmology
Zip code
734-0037
Address
1-2-3, Kasumi, Minamiku, Hiroshima
TEL
082-257-5246
sakaguh@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Komatsu |
Organization
Hiroshima University Hospital
Division name
Ophthalmology
Zip code
734-0037
Address
1-2-3, Kasumi, Minamiku, Hiroshima
TEL
082-257-5246
Homepage URL
kaori110@hiroshima-u.ac.jp
Sponsor or person
Institute
Hirohsima 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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-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
| 2025 | Year | 10 | Month | 02 | 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
| 2025 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study collects the following existing information:
Patient background: Gender, date of birth, age, comorbidities, medical history, current medical history, eye drop usage status
Fundus examination*
Physical examination (slit-lamp microscopy and fundus examination)
Visual acuity test
Intraocular pressure measurement
Visual field test
Optical coherence tomography (OCT)
Confirmation of adverse events
Management information
Registered date
| 2025 | Year | 10 | Month | 02 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067197
