UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042420 |
|---|---|
| Receipt number | R000048409 |
| Scientific Title | Exploratory study of usefulness and challenges in clinical use of polarized-sensitive OCT to the fundus |
| Date of disclosure of the study information | 2020/11/11 |
| Last modified on | 2020/11/11 16:47:17 |
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Basic information
Public title
Exploratory study of usefulness and challenges in clinical use of polarized-sensitive OCT to the fundus
Acronym
Exploratory study of usefulness and challenges in clinical use of polarized-sensitive OCT to the fundus
Scientific Title
Exploratory study of usefulness and challenges in clinical use of polarized-sensitive OCT to the fundus
Scientific Title:Acronym
Exploratory study of usefulness and challenges in clinical use of polarized-sensitive OCT to the fundus
Region
| Japan |
Condition
Condition
Patients with outpatients for whom outpatient observation of the fundus using polarized-sensitive OCT would be useful in understanding the pathophysiology of the disease, specifically, glaucoma, intense myopia, various macular diseases, retinal degenerative diseases, uveitis, ocular tumors, and other diseases, who consent to participate in this clinical study will be included in this study. There is no specific age limit, but in the case of minors or adults who are unable to give their informed consent, a signature of a guardian or guardianship or other equivalent will be required. Because of the exploratory nature of multiple diseases, it is assumed that 300 patients in the macular field, 100 in the glaucoma field, and about 100 in the other fields will be photographed. For the macular field, we expect to take about 40-50 cases per disease because of the wide range of diseases covered.
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to use polarized-sensitive OCT exploratory in clinical settings and to observe cross-sectional images of the ocular fundus to further understand the pathology of the disease and evaluate the usefulness of polarized-sensitive OCT and its problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Polarized-sensitive OCT data of the fundus, image data created by analyzing this, images obtained in normal medical care, examination data, basic information such as gender and date of birth, and general clinical information described in medical records such as medical history
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Move to the location of the polarized OCT installed in the outpatient department, sit on a chair, place your face on the chin of the polarized OCT, and follow the inspector's instructions to gaze at the fixed viewpoint inside the polarized OCT. In cases of ptosis, the inspector should provide appropriate assistance such as supporting the upper eyelid with fingers so that the upper eyelid does not cover the pupil. I'm still still for a few seconds of shooting. The examination ends when the face is separated from the chin rest, and at the same time, the actual experience of clinical research ends. The restraint time is assumed to be about 5 minutes at the longest, and the number of examinations is one outpatient, and if necessary during the follow-up, it will be performed each time. Invasion does not exceed the same minor invasion as normal OCT.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients whose fundus observation using polarizedpsensitive OCT is considered to be meaningful in understanding the pathological condition
Key exclusion criteria
There are no particular exclusion criteria.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kato |
Organization
The University of Tokyo Hospital
Division name
Department of Ophthalmology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
katou-s@ka2-so-net.ne.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Minami |
Organization
The University of Tokyo Hospital
Division name
Department of Ophthalmology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
takaminami-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
The University of Tokyo, Clinical Research Review Board
Address
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo Faculty of Medicine Bldg.2 4F 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2020 | Year | 11 | Month | 11 | 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
| 2018 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 11 | Month | 11 | Day |
Last modified on
| 2020 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048409
