UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035539 |
|---|---|
| Receipt number | R000040492 |
| Scientific Title | Study on the transition of surgical method in Rhegmatogenous retinal detachment |
| Date of disclosure of the study information | 2019/01/15 |
| Last modified on | 2019/01/14 20:10:28 |
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Basic information
Public title
Study on the transition of surgical method in Rhegmatogenous retinal detachment
Acronym
Investigation of the procedure of rheolorogenic retinal detachment
Scientific Title
Study on the transition of surgical method in Rhegmatogenous retinal detachment
Scientific Title:Acronym
Investigation of the procedure of rheolorogenic retinal detachment
Region
| Japan |
Condition
Condition
Rhegmatogenous retinal detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the procedure in cases where surgery was performed on Rhegmatogenous retinal detachment and confirmation of the optimal procedure selection for various retinal detachments
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Statistical analysis is performed on the patient data collected backwards, and the usefulness and recovery ratio of the operation type are examined
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Groups who underwent surgery for retinal detachment and proliferative vitreoretinopath in 3 years from March 2014
Interventions/Control_2
In the group that underwent surgery for retinal detachment and proliferative vitreoretinopathy in 3 years from March 2008
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
| 10 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent surgery for retinal detachment and proliferative vitreoretinopathy in March 2008 and March 2014
Key exclusion criteria
In other hospitals, cases in which surgery was performed on rhabdominal retinal detachment, proliferative vitreoretinopathy, retinal detachment of perforating ocular trauma, and macular hole retinal detachment were excluded.
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Yamada |
Organization
Kyorin University Medical School Attached Hospital
Division name
ophthalmology
Zip code
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5512
kenji.ltor.kigkb@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Yamada |
Organization
Kyorin University Medical School Attached Hospital
Division name
ophthalmology
Zip code
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5512
Homepage URL
kenji.ltor.kigkb@gmail.com
Sponsor or person
Institute
Kyorin University Medical School Attached Hospital
ophthalmology
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Address
Tel
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
| 2019 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 14 | Day |
Last modified on
| 2019 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040492
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| Registered date | File name |
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| Registered date | File name |
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