UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046555 |
|---|---|
| Receipt number | 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 | 2023/01/15 18:20:04 |
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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
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
sonosho0110@gmail.com
Sponsor or person
Institute
Kagoshima Sonoda eye & plastic surgery clinic
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053100
