UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030032 |
|---|---|
| Receipt number | R000034275 |
| Scientific Title | The observation of ocular tissue using magnification adaptor |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2025/04/30 17:05:55 |
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Basic information
Public title
The observation of ocular tissue using magnification adaptor
Acronym
The observation of ocular tissue using magnification adaptor
Scientific Title
The observation of ocular tissue using magnification adaptor
Scientific Title:Acronym
The observation of ocular tissue using magnification adaptor
Region
| Japan |
Condition
Condition
Various kind of ocular diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To take magnified images of ocular tissue using magnification adaptor at the time of image acquisition using SPectralis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of absence of new findings that are detected using magnification adaptor
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
To take images using magnification adaptor when images are taken without magnification adaptor.
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
Subjects who have examinations with Spectralis.
Key exclusion criteria
Subjects who refused the examinations with
magnification adaptor.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuki Ito |
Organization
Nagoya University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL
052-741-2111
yasu@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuki Ito |
Organization
Nagoya University Graduate School of Medicine
Division name
Ophthalmology
Zip code
Address
65 Tsuruma-cho, Showa-ku, Nagoya, Japan
TEL
052-741-2111
Homepage URL
yasu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Heidelberg Engineering
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 04 | 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
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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | 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
| 2017 | Year | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034275
