UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024096 |
|---|---|
| Receipt number | 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 | 2019/12/05 17:57:08 |
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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 | 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
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
kenkojim@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027740
