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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011739
Receipt No. R000013724
Scientific Title Comparison of vitrectomy outcomes for eyes with proliferative vitreoretinopathy with various silicon oil.
Date of disclosure of the study information 2013/09/12
Last modified on 2013/09/12

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Basic information
Public title Comparison of vitrectomy outcomes for eyes with proliferative vitreoretinopathy with various silicon oil.
Acronym Comparison of vitrectomy outcomes with various silicon oil
Scientific Title Comparison of vitrectomy outcomes for eyes with proliferative vitreoretinopathy with various silicon oil.
Scientific Title:Acronym Comparison of vitrectomy outcomes with various silicon oil
Region
Japan

Condition
Condition proliferative vitreoretinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare vitrectomy outcomes for eyes with proliferative vitreoretinopathy with various silicon oil.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity
intraocular pressure
fundus examination
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 SIL-5000



Interventions/Control_2 Siluron2000
Interventions/Control_3 Siluron5000
Interventions/Control_4 Densiron68
Interventions/Control_5 Oxane HD
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the patient who will perform proliferative vitreous surgery
Key exclusion criteria 1)This agent ingredient hypersensitivity
2)The patient who this research responsibility (assignment) doctor accepted was unsuitable as a subject
3)The patient who has other ocular complications or systemic complications was unsuitable for silicon oil injection.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koh-Hei Sonoda
Organization Yamaguchi University Graduate School of Medicine
Division name Ophthalmology
Zip code
Address Ube City, Yamaguchi 755-8505, Japan
TEL +81-836-222278
Email sonodak@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Kimura
Organization Yamaguchi University Graduate School of Medicine
Division name Ophthalmology
Zip code
Address Ube City, Yamaguchi 755-8505, Japan
TEL +81-836-222278
Homepage URL
Email k.kimura@yamaguchi-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
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
Address
Tel
Email

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
2013 Year 09 Month 12 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 Open public recruiting
Date of protocol fixation
2012 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 12 Day
Last modified on
2013 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013724


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