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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046555
Receipt No. R000053100
Scientific Title Home-OCT; evaluation of usability of eyeMO Retinal OCT
Date of disclosure of the study information 2022/01/10
Last modified on 2022/01/05

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Basic information
Public title Home-OCT; evaluation of usability of eyeMO Retinal OCT
Acronym Evaluation of usability of Home-OCT
Scientific Title Home-OCT; evaluation of usability of eyeMO Retinal OCT
Scientific Title:Acronym Evaluation of usability of Home-OCT
Region
Japan

Condition
Condition healthy eye, corioretinal disease eye
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Through the home-OCT prototype for patients, to verify the usability of the device and the accuracy of the measured retinal morphology data, which will lead to further improvement of home-OCT.
Basic objectives2 Others
Basic objectives -Others Evaluation of the usability of the equipment
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of usability and operability of home-OCT based on the time required to complete acquisition
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 Taking a retinal image with Home-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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients over 20 years
Patients with written consent for participation in the study
Key exclusion criteria Patients with corneal opacity that may affect OCT images
Patients judged to be inappropriate as a target by the judgment of a doctor
Target sample size 40

Research contact person
Name of lead principal investigator
1st name shozo
Middle name
Last name sonoda
Organization Kagoshima Sonoda eye & plastic surgery clinic
Division name Ophthalmology
Zip code 890-0053
Address 29-4,chu-oh cho, Kagoshima city, Kagoshima
TEL 099-210-5311
Email sonosho0110@gmail.com

Public contact
Name of contact person
1st name Shozo
Middle name
Last name Sonoda
Organization Kagoshima Sonoda eye & plastic surgery clinic
Division name Ophthalmology
Zip code 890-0053
Address 29-4,chu-oh cho, Kagoshima city, Kagoshima
TEL 099-210-5311
Homepage URL
Email sonosho0110@gmail.com

Sponsor
Institute Kagoshima Sonoda eye & plastic surgery clinic
Institute
Department

Funding Source
Organization Kagoshima Sonoda eye & plastic surgery clinic
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 Yamauchi Clinic Research Ethics Committee
Address 1-15-19, Jiyugaoka, Meguro-ku, Tokyo
Tel 03-6777-1490
Email yanagimoto.atsuko@neues.co.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
2022 Year 01 Month 10 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
2021 Year 11 Month 16 Day
Date of IRB
2021 Year 12 Month 16 Day
Anticipated trial start date
2022 Year 01 Month 10 Day
Last follow-up date
2022 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
2022 Year 01 Month 05 Day
Last modified on
2022 Year 01 Month 05 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053100

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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