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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017327
Receipt No. R000020058
Scientific Title Brilliant blue G assisted internal limiting membrane peeling in vitrectomy
Date of disclosure of the study information 2015/06/01
Last modified on 2019/05/08

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Basic information
Public title Brilliant blue G assisted internal limiting membrane peeling in vitrectomy
Acronym BBG assisted ILM peeling
Scientific Title Brilliant blue G assisted internal limiting membrane peeling in vitrectomy
Scientific Title:Acronym BBG assisted ILM peeling
Region
Japan

Condition
Condition macular hole, epiretinal membrane, macular edema,retinoschisis, proliferative vitreoretinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and the safety of brillinat blue G assisted ILM peeling in vitreectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the adverse effect
Key secondary outcomes the rate of complete ILM peeling
the rate of macular hole closure
the best corrected visual acuity at 1,3,6,12,and 24 months after surgery
the visual field at 6 months after surgery

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The staining with brilliant blue G for ILM peeling
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

Not applicable
Gender Male and Female
Key inclusion criteria The patients with macular hole, macular edema, epiretinal membrane,retinoschisis, or proliferative vitreoretinopathy after ophthlalmic examination at Matsumoto Dental University Hospital. Surgical treatment is required for them.
Key exclusion criteria the patients with glaucoma
nursing women, pregnant women
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kouichi
Middle name
Last name Ohta
Organization Matsumoto Dental Univesiry
Division name Department of Ophthalmology
Zip code 399-0781
Address 1780 Gobara, Hiooka, Shiojiri
TEL 0263-51-2360
Email ohta@po.mdu.ac.jp

Public contact
Name of contact person
1st name Kouichi
Middle name
Last name Ohta
Organization Matsumoto Dental Univeristy
Division name Department of Ophthalmology
Zip code 399-0781
Address 1780 Gobara, Hirooka, Shiojiri
TEL 0263-51-2360
Homepage URL
Email ohta@po.mdu.ac.jp

Sponsor
Institute Matsumoto Dental University,
Department of Ophthalmology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Matsumoto Dental University
Address 1780 Gobara, Hirooka, Shiojiri
Tel 0263-51-2188
Email info_kakenhi@po.mdu.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
2015 Year 06 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 36
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 Terminated
Date of protocol fixation
2015 Year 05 Month 31 Day
Date of IRB
2015 Year 06 Month 02 Day
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
2019 Year 05 Month 31 Day
Date trial data considered complete
2019 Year 05 Month 31 Day
Date analysis concluded
2019 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 29 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020058

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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