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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044516
Receipt No. 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

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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
Email 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
Email okado.satoshi@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050834

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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