UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017327 |
|---|---|
| Receipt number | 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 12:19:21 |
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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
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
ohta@po.mdu.ac.jp
Sponsor or person
Institute
Matsumoto Dental University,
Department of Ophthalmology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020058
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
