UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043808 |
|---|---|
| Receipt number | R000049829 |
| Scientific Title | Confirmation of the principle of multifunctional OCT for ocular imaging |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2024/04/03 12:09:46 |
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Basic information
Public title
Confirmation of the principle of multifunctional OCT for ocular imaging
Acronym
Observation of the eye using multi-function OCT
Scientific Title
Confirmation of the principle of multifunctional OCT for ocular imaging
Scientific Title:Acronym
Observation of the eye using multi-function OCT
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the principle of operation and image characteristics of eye observation using an optical coherence tomograph developed for research purposes.
Basic objectives2
Others
Basic objectives -Others
To evaluate the microstructure in the eye using optical coherence tomography
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microstructure change
Ocular blood flow
Key secondary outcomes
Distribution of Melanin
Distribution of fibrotic tissues
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those without definite eye disease
Key exclusion criteria
Subjects for whom it is difficult to confirm their consent to participate in the research
Patients with definite eye diseases
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Makita |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8573
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-5217
makita@optlab2.bk.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Makita |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8573
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-5217
Homepage URL
makita@optlab2.bk.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Topcon Coorporation
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
0298533429
sien.ningenss@un.tsukuba.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
| 2021 | Year | 09 | 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
In some healthy volunteers' eye, digital refocusing and aberration correction worked. It is confirmed that blurred fine structures are restored.
Results date posted
| 2024 | Year | 04 | Month | 03 | Day |
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
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will conduct ocular imaging using multi-function OCT to confirm the principle and verify the operation.
Management information
Registered date
| 2021 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049829
