UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039495 |
|---|---|
| Receipt number | R000044971 |
| Scientific Title | Retrospective clinical evaluation of chorioretinal disease |
| Date of disclosure of the study information | 2020/02/16 |
| Last modified on | 2023/08/19 10:34:04 |
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Basic information
Public title
Retrospective clinical evaluation of chorioretinal disease
Acronym
Retrospective clinical evaluation of chorioretinal disease
Scientific Title
Retrospective clinical evaluation of chorioretinal disease
Scientific Title:Acronym
Retrospective clinical evaluation of chorioretinal disease
Region
| Japan |
Condition
Condition
chorioretinal disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the associated clinical factors of chorioretinal disease for visual function
Basic objectives2
Others
Basic objectives -Others
To retrospectively evaluate the association of clinical factors and visual function in chorioretinal disease
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
visual acuity. visual field, color vision
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
The patients with chorioretinal disorders who underwent examination or treatment at department of Ophthalmology in Tokyo Medical University, Ibaraki Medical Center.
Key exclusion criteria
The patients who refuse to participate this study.
Target sample size
7500
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Miura |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Dept. of Ophthalmology
Zip code
3000395
Address
3-20-1 Chuo, Ami, Inashiki, Ibaraki
TEL
029-8871161
m-miura@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Miura |
Organization
Tokyo Medical University Ibaraki Medical Center
Division name
Dept. of Ophthalmology
Zip code
3000395
Address
3-20-1 Chuo, Ami, Inashiki, Ibaraki
TEL
029-8871161
Homepage URL
http://www.tokyo-med.ac.jp/iba-eye/IRB_list.html
m-miura@tokyo-med.ac.jp
Sponsor or person
Institute
Dept. of Ophthalmology,Tokyo Medical University Ibaraki Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tokyo Medical University
Address
6-1-1 Nishi-shinjuku, Shinjuku, Tokyo 1600023 Japan
Tel
03-3351-6141
irb@tokyo-med.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
| 2020 | Year | 02 | Month | 16 | Day |
Related information
URL releasing protocol
http://www.tokyo-med.ac.jp/iba-eye/IRB_list.html
Publication of results
Partially published
Result
URL related to results and publications
https://www.dovepress.com/modified-low-power-mode-laser-for-the-treatment-of-central-serous-chor-pee
Number of participants that the trial has enrolled
4
Results
Treatment efficacy of low power mode laser for central serous chorioretinopathy
Results date posted
| 2021 | Year | 02 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 30 | Day |
Baseline Characteristics
central serous chorioretinopathy
Participant flow
Adverse events
None
Outcome measures
OCT finding
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective, non-invasive, observational study
Management information
Registered date
| 2020 | Year | 02 | Month | 16 | Day |
Last modified on
| 2023 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044971
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/08/18 | 研究実施計画書_網膜後ろ向き2020017修正承認.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
