UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011338 |
|---|---|
| Receipt number | R000013261 |
| Scientific Title | Staining by Brilliant Blue G in the intraocular surgery |
| Date of disclosure of the study information | 2013/08/01 |
| Last modified on | 2013/07/31 08:48:57 |
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Basic information
Public title
Staining by Brilliant Blue G in the intraocular surgery
Acronym
Staining by Brilliant Blue G in the intraocular surgery
Scientific Title
Staining by Brilliant Blue G in the intraocular surgery
Scientific Title:Acronym
Staining by Brilliant Blue G in the intraocular surgery
Region
| Japan |
Condition
Condition
Ophthalmic diseases targeted for intraocular surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Performing staining of the intraocular tissue by Brilliant Blue G to carry out the surgery safely during intraocular surgery and evaluate visual acuity,field of view,retinal thickness after surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the visual acuity, retinal thickness, field of view after surgery, evaluate the safety of the surgery method using this drug as compared to the conventional method.
Key secondary outcomes
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
Use of Brilliant Blue G of the intraocular tissue staining during intraoperative surgery
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
1) During intraocular surgery cases staining is necessary to anterior capsule of the lens and internal limiting membrane of the retina.
2) Patients were able gain agreement with from the person.
Key exclusion criteria
1) Patients who may have been pregnant or pregnant women, patients who wish pregnancy and patient breastfeeding
2) External eye disease activity
3) Patients physician deems inappropriate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Sugiyama |
Organization
Kanazawa University
Division name
Department of Ophthalmology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiharu Shimizu |
Organization
Kanazawa University
Division name
Department of Ophthalmology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, Kanazawa University
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
Address
Tel
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 | 08 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 01 | Day |
Last modified on
| 2013 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013261
| 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 |
