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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024096
Receipt No. R000027740
Scientific Title Clinical study of suprachoroidal buckling for rhegmatogenous retinal detachment
Date of disclosure of the study information 2016/09/30
Last modified on 2019/03/22

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Basic information
Public title Clinical study of suprachoroidal buckling for rhegmatogenous retinal detachment
Acronym Suprachoroidal buckling for RRD
Scientific Title Clinical study of suprachoroidal buckling for rhegmatogenous retinal detachment
Scientific Title:Acronym Suprachoroidal buckling for RRD
Region
Japan

Condition
Condition Rhegmatogenous retinal detachment
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of suprachoroidal buckling for rhegmatogenous retinal detachment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Anatomical retinal attachment rate 1 year after surgery.
Key secondary outcomes Visual acuity, Intraocular pressure, Refractive error, OCT, Ultrasound B scan 1 week, 1 month, 3 months, 6 months and 1 year after surgery.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Suprachoroidal space is exposed by making scleral incision in the quadrant of retinal tear. After guiding the cannula or catheter beneath the tear, suprachoroidal filler is injected to indent the choroid alone to close the retinal tear through the suprachoroidal space.
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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria 1. Primary rhegmatogenous retinal detachment
2. Written informed consent
Key exclusion criteria 1. Proliferative vitreoretinopathy
2. History of former surgery for rhegmatogenous retinal detachment
3. others (inappropriate case judged by investigator or subinvestigators)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chie Sotozono
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
TEL 075-251-5578
Email sotozon@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Kojima
Organization Kyoto Prefectural University of Medicine
Division name Department of Ophthalmology
Zip code
Address 465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
TEL 075-251-5578
Homepage URL
Email kenkojim@koto.kpu-m.ac.jp

Sponsor
Institute Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Self funding
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
2016 Year 09 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
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 No longer recruiting
Date of protocol fixation
2013 Year 11 Month 29 Day
Date of IRB
2014 Year 01 Month 07 Day
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 18 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027740

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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