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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029720
Receipt No. R000033962
Scientific Title Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Date of disclosure of the study information 2017/12/01
Last modified on 2017/10/26

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Basic information
Public title Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Acronym Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Scientific Title Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Scientific Title:Acronym Feasibility assessment of intraoperative endoillumination with controlled spectral distribution.
Region
Japan

Condition
Condition vitreoretinal diseases (epiretinal membrane, macular hole, diabetic retinopathy, retinal detachment, retinal hemorrhage)
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess visibility of retinal lesions using endoillumination with controlled spectral distribution during surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes rate of intraoperative complication
Key secondary outcomes visibility of retinal lesion

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 use endoillumination with control spectral distribution light source for about 5 minuits per surgery.
Interventions/Control_2 use endoillumination with usual light source
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

Not applicable
Gender Male and Female
Key inclusion criteria one who will receive vitreoretinal surgery
Key exclusion criteria one without consent
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sujin Hoshi
Organization Faculty of Medicine, University of Tsukuba
Division name Ophthalmology
Zip code
Address 1-1-1 Tennoudai, Tsukuba-city, Ibaraki, Japan
TEL 029-853-3148
Email hoshisujin@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sujin Hoshi
Organization Faculty of Medicine, University of Tsukuba
Division name Ophthalmology
Zip code
Address 1-1-1 Tennoudai, Tsukuba-city, Ibaraki, Japan
TEL 029-853-3148
Homepage URL
Email hoshisujin@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba
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
2017 Year 12 Month 01 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
2017 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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
2017 Year 10 Month 26 Day
Last modified on
2017 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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