UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058827 |
|---|---|
| Receipt number | R000067271 |
| Scientific Title | Quantitative Evaluation of Intraocular Structures and Validation of Clinical Utility Using Next-Generation Swept-Source Optical Coherence Tomography |
| Date of disclosure of the study information | 2025/08/31 |
| Last modified on | 2025/08/18 19:11:42 |
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Basic information
Public title
Quantitative Evaluation of Intraocular Structures and Validation of Clinical Utility Using Next-Generation Swept-Source Optical Coherence Tomography
Acronym
Assessment of Intraocular Structures with Next-Generation SS-OCT
Scientific Title
Quantitative Evaluation of Intraocular Structures and Validation of Clinical Utility Using Next-Generation Swept-Source Optical Coherence Tomography
Scientific Title:Acronym
Assessment of Intraocular Structures with Next-Generation SS-OCT
Region
| Japan |
Condition
Condition
diabetic retinopathy, age-related macular degeneration, retinal vein occlusion, rhegmatogenous retinal detachment, retinitis pigmentosa, glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the clinical utility of next-generation swept-source optical coherence tomography (OCT) in assisting diagnosis and assessing disease severity of various ocular disorders, including age-related macular degeneration, diabetic retinopathy, and neovascular glaucoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
retino-choroidal thickness
Key secondary outcomes
retinal vascular perfusion density
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients having an underlying ocular disorder
Key exclusion criteria
patients with poor fixation
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Kadomoto |
Organization
Kyoto University
Division name
Ophthalmology
Zip code
606-8507
Address
Kyoto City Sakyo-Ku Shogo-in Kawara-Cho 54
TEL
075-751-3727
kadomoto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Kadomoto |
Organization
Kyoto University
Division name
Ophthalmology
Zip code
606-8507
Address
Kyoto City Sakyo-Ku Shogo-in Kawara-Cho 54
TEL
080-3951-6021
Homepage URL
kadomoto@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Ophthalmology Research Grant
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Kyoto City Sakyo-Ku Shogo-in Kawara-Cho 54
Tel
075-366-7618
ethcom@kuhp.kyoto-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 | 08 | Month | 31 | 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 | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The device used in this study offers several improvements over conventional OCT systems, including higher imaging speed, enhanced spatial resolution, a wider scanning area, and greater acquisition stability, enabling more detailed visualization of retinal layer structures and the choroid. In addition, simultaneously acquired near-infrared reflectance images facilitate evaluation while allowing precise correlation between structural features and vascular localization.
Management information
Registered date
| 2025 | Year | 08 | Month | 18 | Day |
Last modified on
| 2025 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067271
