UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study on intraocular tamponade used for rhegmatogenous retinal detachment
Acronym	Prospective study on intraocular tamponade used for rhegmatogenous retinal detachment
Scientific Title	Prospective study on intraocular tamponade used for rhegmatogenous retinal detachment
Scientific Title:Acronym	Prospective study on intraocular tamponade used for rhegmatogenous retinal detachment
Region	Japan

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

Objectives
Narrative objectives1	Make selection standard for intraocular tamponade
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Final vision acuity
Key secondary outcomes	Postoperative visual acuity , recurrence

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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with rhegmatogenous retinal detachment treated at Yamagata University Hospital. Patient who could get consent. 16 years old or older.
Key exclusion criteria	Patient who has withdrawn consent.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hidetoshi Middle name Last name Yamashita
Organization	Yamagata University
Division name	Ophthalmology
Zip code	990-9585
Address	2-2-2, Iida Nishi, Yamagata, Japan
TEL	+81-23-628-5000
Email	hyama-tky@umin.ac.jp

Public contact
Name of contact person	1st name Madoka Middle name Last name Nakamura
Organization	Yamagata University
Division name	Ophthalmology
Zip code	990-9585
Address	2-2-2, Iida Nishi, Yamagata, Japan
TEL	+81-23-628-5000
Homepage URL
Email	m-okochi@med.id.yamagata-u.ac.jp

Sponsor
Institute	Yamagata University
Institute
Department

Funding Source
Organization	Yamagata 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	Yamagata Univercity
Address	2-2-2, Iida Nishi, Yamagata, Japan
Tel	+81-23-628-5000
Email	m-okochi@med.id.yamagata-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	2019 Year 07 Month 05 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	Preinitiation
Date of protocol fixation	2019 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Air selection standard Within 2 weeks after onset Not strong myopia No history of cataract surgery complications Not proliferative vitreoretinopathy grade C or higher

Management information
Registered date	2019 Year 07 Month 05 Day
Last modified on	2019 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042498