UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044516 |
|---|---|
| Receipt number | R000050834 |
| Scientific Title | Analysis of Electroretinogram Data in Nagoya University Hospital |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/06/12 22:31:32 |
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Basic information
Public title
Analysis of Electroretinogram Data in Nagoya University Hospital
Acronym
Analysis of Electroretinogram Data in Nagoya University Hospital
Scientific Title
Analysis of Electroretinogram Data in Nagoya University Hospital
Scientific Title:Acronym
Analysis of Electroretinogram Data in Nagoya University Hospital
Region
| Japan |
Condition
Condition
retinal disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this project is to record electroretinograms of various retinal diseases and before and after surgeries of retinal diseases, and to accumulate and analyze the data in our hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amplitude and implicit time of full-field electroretinogram, multifocal electroretinogram, and focal macular electroretinogram
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Record electroretinograms at the time of diagnosis of patients with retinal diseases. If surgery is required, the electroretinogram should be recorded before surgery and at 1 week, 1 month, 3 months, 6 months, and 1 year after surgery. The timing and number of measurements may be adjusted according to the postoperative situation.
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
Age 20 years or older at the time of obtaining consent.
Can record electroretinograms using contact lens electrodes or skin electrodes.
Those who have given sufficient explanation of this research to the subject using an explanatory document and have obtained the subject's written consent for participation of their own free will.
Key exclusion criteria
Women who are pregnant or may become pregnant (Because of the precautions in the package insert for ophthalmic surface anesthetics).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Okado |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
466-0065
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
TEL
0527442275
okado.satoshi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Okado |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
466-0065
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
TEL
0527442275
Homepage URL
okado.satoshi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Panasonic
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Bioethics Review Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture
Tel
0527412111
ethics@med.nagoya-u.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
| 2021 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 12 | Day |
Last modified on
| 2021 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050834
