UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046251 |
|---|---|
| Receipt number | R000052779 |
| Scientific Title | Analysis of brain-sensory network focusing on neural retinal circuit |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2021/12/01 16:02:06 |
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Basic information
Public title
Analysis of brain-sensory network focusing on neural retinal circuit
Acronym
retina and brain-sensory network
Scientific Title
Analysis of brain-sensory network focusing on neural retinal circuit
Scientific Title:Acronym
retina and brain-sensory network
Region
| Japan |
Condition
Condition
inherited retinal diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether there is auditory and brain dysfunction in hereditary retinal diseases that involve damage to retinal bipolar cells.
Basic objectives2
Others
Basic objectives -Others
Patients with hereditary retinal diseases will be examined for abnormalities in hearing tests.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective auditory function test
Key secondary outcomes
Objective auditory function test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Patients with inherited retinal disorders
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
| 6 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with stationary night blindness or retinoschisis
Key exclusion criteria
Patients under 6 years old or who do not consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Ueno |
Organization
Nagoya University Graduate school of Medicine
Division name
Ophthalmology
Zip code
466-8550
Address
65 Tsuruma-cho Show-ku Nagoya city
TEL
052-744-2275
ueno@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Ueno |
Organization
Nagoya University Graduate school of Medicine
Division name
Ophthalmology
Zip code
466-8550
Address
65 Tsuruma-cho Show-ku Nagoya city
TEL
052-744-2275
Homepage URL
ueno@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate school of Medicine
Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate school of Medicine
Address
65 Tsuruma-cho Show-ku Nagoya city
Tel
052-744-2973
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 12 | Month | 01 | Day |
Last modified on
| 2021 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052779
