UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015355 |
|---|---|
| Receipt number | R000017860 |
| Scientific Title | Anterior lens capsule staining by VisionBlue(R) in cataract surgery |
| Date of disclosure of the study information | 2014/10/06 |
| Last modified on | 2015/10/09 18:22:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Anterior lens capsule staining by VisionBlue(R) in cataract surgery
Acronym
Anterior capsule staining by VisionBlue(R)
Scientific Title
Anterior lens capsule staining by VisionBlue(R) in cataract surgery
Scientific Title:Acronym
Anterior capsule staining by VisionBlue(R)
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
VisionBlue(R)(DORC International) is not approved in Japan. The object of this study is verifying safety and efficacy of VisionBlue(R) .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
An indicator of the safety is corneal endothelial cell density, compared between preoperative and one month after surgery , if it has decreased 500cells / mm2 or more.
An indicator of the effectiveness is visibility of the anterior capsule of the lens, compared before and after dyeing.
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
VisionBlue(R)
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
Cases of mature cataract, 4-5 degrees nuclear sclerosis cataract , cataract with corneal 0r vitreous opacity ,cataract with bad isibility of the anterior capsule.
Key exclusion criteria
Patients under the age of 20, during pregnancy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Shinoda |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
shinoha@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidemasa Torii |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
hidemasatorii@yahoo.co.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
| 2014 | Year | 10 | Month | 06 | 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
2 cases in 10 cases were dropped out.
three cases in eight cases showed a decrease of the number of corneal endothelial cells .But, the visibility of the lens anterior capsule was good in all cases.
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 06 | Day |
Last modified on
| 2015 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017860
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
