UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031510 |
|---|---|
| Receipt number | R000035736 |
| Scientific Title | Staining with brilliant blue G for the internal limiting membrane |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2024/03/03 21:46:45 |
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Basic information
Public title
Staining with brilliant blue G for the internal limiting membrane
Acronym
Brilliant blue G stains the internal limiting membrane
Scientific Title
Staining with brilliant blue G for the internal limiting membrane
Scientific Title:Acronym
Brilliant blue G stains the internal limiting membrane
Region
| Japan |
Condition
Condition
macular hole, epiretinal membrane, BRVO or Diabetic retinopathy with macular edema, proliferative retinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of brilliant blue for visualization of the internal limiting membrane during and after vitrectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity, IOP, fundus, visual field, ERG, and OCT
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cases requiring the internal limiting membrane peeling during vitrectomy
Key exclusion criteria
Patients do not wish to use the BBG during vitrectomy.
Patients attending physician has determined ineligible (drug allergy, alcoholics etc).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kiyofumi |
| Middle name | |
| Last name | Mochizuki |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
5011194
Address
1-1 Yanagido, Gifu-shi, Gifu
TEL
058-230-6288
mochi-gif@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kiyofumi |
| Middle name | |
| Last name | Mochizuki |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
5011194
Address
1-1 Yanagido, Gifu-shi, Gifu
TEL
058-230-6288
Homepage URL
mochi-gif@umin.ac.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu 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
Gifu University School of Medicine
Address
1-1 Yangido Gifu
Tel
058-230-6059
gjme00005@jim.gifu-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
| 2023 | Year | 03 | Month | 31 | 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
0
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
| 2018 | Year | 02 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
The trial was stopped because the coronary catastrophe made it impossible to carry out the necessary tests.
Management information
Registered date
| 2018 | Year | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035736
