UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061798 |
|---|---|
| Receipt number | R000070690 |
| Scientific Title | Assessment of Ocular Conditions Using Multimodal Ophthalmic Imaging |
| Date of disclosure of the study information | 2026/06/04 |
| Last modified on | 2026/06/04 17:30:43 |
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Basic information
Public title
Assessment of Ocular Conditions Using Multimodal Ophthalmic Imaging
Acronym
Assessment of Ocular Conditions Using Multimodal Ophthalmic Imaging
Scientific Title
Assessment of Ocular Conditions Using Multimodal Ophthalmic Imaging
Scientific Title:Acronym
Assessment of Ocular Conditions Using Multimodal Ophthalmic Imaging
Region
| Japan |
Condition
Condition
All conditions requiring ophthalmic management
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the distribution and variability of quantitative parameters obtained from non-invasive ophthalmic examinations in healthy individuals and patients with various ophthalmic diseases, as well as the factors influencing these parameters.
Basic objectives2
Others
Basic objectives -Others
Ophthalmic imaging assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Retinal thickness measured by OCT, and vessel density and vessel length measured by OCT angiography.
Key secondary outcomes
Other ophthalmic examination findings, including visual function tests, ophthalmic imaging examinations, and other ophthalmic assessments.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Healthy volunteers will undergo ophthalmic imaging examinations, including OCT and OCT angiography. Pupil dilation may be performed when necessary. For patients, data obtained during clinical care will be used for research purposes, and no additional research-specific interventions will be performed.
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
| 3 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visit the ophthalmology department for examination or treatment of eligible ophthalmic conditions and provide informed consent for participation in the study, as well as healthy individuals without ophthalmic disease.
Target conditions: All conditions requiring ophthalmic management
Age: 3 years or older
Key exclusion criteria
Individuals from whom informed consent cannot be obtained directly (except for minors whose legally authorized representative provides consent).
Individuals who are unable to maintain fixation or the required examination posture, making acquisition of the necessary examination data difficult.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Hamamatsu university school of medicine
Division name
Department of ophthalmology
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka
TEL
053-435-2256
h-kaneko@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kaoruko |
| Middle name | |
| Last name | Torii |
Organization
Hamamatsu university school of medicine
Division name
Department of ophthalmology
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka
TEL
053-435-2256
Homepage URL
kaorukot@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu university school of medicine
Institute
Department
Personal name
Hiroki Kaneko
Funding Source
Organization
Hamamatsu university school of medicine
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
Hamamatsu University School of Medicine, Life Science and Medical Research Ethics Committee
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu city, Shizuoka, 431-3192, Japan
Tel
053-435-2680
rinri@hama-med.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
| 2026 | Year | 06 | Month | 04 | 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
| 2026 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 04 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070690
