UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047620 |
|---|---|
| Receipt number | R000054303 |
| Scientific Title | Impact of Perfluoron Carbon on Postoperative Outcomes by Retinal Detachment Type |
| Date of disclosure of the study information | 2022/04/28 |
| Last modified on | 2022/04/28 17:23:52 |
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Basic information
Public title
Impact of Perfluoron Carbon on Postoperative Outcomes by Retinal Detachment Type
Acronym
Impact of PFCL on Postoperative Outcomes by RD Type
Scientific Title
Impact of Perfluoron Carbon on Postoperative Outcomes by Retinal Detachment Type
Scientific Title:Acronym
Impact of PFCL on Postoperative Outcomes by RD Type
Region
| Japan |
Condition
Condition
retinal detachment
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the use of PFCL for rhegmatogenous retinal detachment (RRD) other than refractory retinal detachment affects the frequency of retinal re-detachment after initial surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of reablation incidence at 6 months postoperatively for initial surgery for RRD.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
RRD patients diagnosed between February 1, 2016 and March 31, 2017 who underwent vitrectomy
Key exclusion criteria
Cases with missing key information
Cases with unknown PFCL use
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University
Division name
Department of Ophthalmology, Graduate School of Medicine
Zip code
514-8507
Address
Edobashi
TEL
0592315027
sugmochi@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Sugimoto |
Organization
Mie University
Division name
Department of Ophthalmology, Graduate School of Medicine
Zip code
514-8507
Address
2-174, Edobashi, Tsu, Mie, Japan
TEL
0592315027
Homepage URL
sugmochi@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie University
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
Mie University
Address
2-174, Edobashi, Tsu, Mie, Japan
Tel
0592315027
sugmochi@clin.medic.mie-u.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
| 2022 | Year | 04 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The use of perfluorocarbons (PFCLs) for refractory retinal detachments such as proliferative vitreoretinopathy (PVR) and giant retinal detachments has been approved and their usefulness is known. In this study, we will examine whether the use of PFCL for rhegmatogenous retinal detachment (RRD) other than refractory retinal detachment affects the frequency of retinal re-detachment after initial surgery using the Vitreoretinal Surgery Treatment Information Database established by the Japanese Society for Vitreoretinal Research.
Management information
Registered date
| 2022 | Year | 04 | Month | 28 | Day |
Last modified on
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054303
