UMIN-CTR Clinical Trial

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
Email	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
Email	sugmochi@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054303