UMIN-CTR Clinical Trial

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
Email	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
Email	takaminami-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048409