UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035072 |
|---|---|
| Receipt number | R000039986 |
| Scientific Title | Long-term prognosis of serous retinal detachment associated with tilted disc syndrome: a retrospective multicenter survey |
| Date of disclosure of the study information | 2018/11/30 |
| Last modified on | 2020/02/19 00:10:28 |
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Basic information
Public title
Long-term prognosis of serous retinal detachment associated with tilted disc syndrome:
a retrospective multicenter survey
Acronym
Long-term prognosis of eyes with tilted disc syndrome-associated serous retinal detachment
Scientific Title
Long-term prognosis of serous retinal detachment associated with tilted disc syndrome:
a retrospective multicenter survey
Scientific Title:Acronym
Long-term prognosis of eyes with tilted disc syndrome-associated serous retinal detachment
Region
| Japan |
Condition
Condition
tilted disc syndrome
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate long-term prognosis of eyes with Tilted disc syndrome-associated serous retinal detachment by a multi-center survey.
Basic objectives2
Others
Basic objectives -Others
Observation of long-term prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The best collected visual acuity at baseline and last visit.
Key secondary outcomes
change of serous retinal detachment and central retinal thickness
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
Diagnosed as TDS-associated serous retinal detachment with follow-up of 12 months or longer
Key exclusion criteria
high myopia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Ophthalmology and Visual Science
Zip code
467-0001
Address
1 Kawasumi, Mizuho, Nagoya, Japan
TEL
052-853-8251
yasukawa@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Ophthalmology and Visual Science
Zip code
467-0001
Address
1 Kawasumi, Mizuho, Nagoya, Japan
TEL
052-853-8251
Homepage URL
yasukawa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
clinical research management center
Address
1 Kawasumi, Mizuho, Nagoya, Japan
Tel
052-858-7215
ctmc@med.nagoya-cu.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
| 2018 | Year | 11 | Month | 30 | 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
48
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
| 2017 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigated regarding intervention, histroy of intervention, best collected visual acuity, change of serous retinal detachment and central retinal thickness on optical coherence tomography.
Management information
Registered date
| 2018 | Year | 11 | Month | 29 | Day |
Last modified on
| 2020 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039986
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
