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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000035539
Receipt No. 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

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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
Email 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
Email kenji.ltor.kigkb@gmail.com

Sponsor
Institute Kyorin University Medical School Attached Hospital
ophthalmology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040492

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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