UMIN-CTR Clinical Trial

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 Chie Middle name Last name Sotozono
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Zip code	602-8566
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 Kentaro Middle name Last name Kojima
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Ophthalmology
Zip code	602-8566
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	institutional review board of the Kyoto Prefectural University of Medicine
Address	465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
Tel	075-251-5337
Email	rinri@koto.kpu-m.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	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	Completed
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 12 Month 05 Day

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