UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029691 |
|---|---|
| Receipt number | R000033927 |
| Scientific Title | Prospective Evaluation of Bleb Fluid After Baerveldt Glaucoma Implantation Using Magnetic Resonance Imaging |
| Date of disclosure of the study information | 2017/10/26 |
| Last modified on | 2020/04/27 13:42:57 |
* 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
Prospective Evaluation of Bleb Fluid After Baerveldt Glaucoma Implantation Using Magnetic Resonance Imaging
Acronym
Prospective Evaluation of Bleb Fluid After Baerveldt Glaucoma Implantation Using Magnetic Resonance Imaging
Scientific Title
Prospective Evaluation of Bleb Fluid After Baerveldt Glaucoma Implantation Using Magnetic Resonance Imaging
Scientific Title:Acronym
Prospective Evaluation of Bleb Fluid After Baerveldt Glaucoma Implantation Using Magnetic Resonance Imaging
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate bleb structure after Baerveldt glaucoma implantation from early postoperative time using magnetic resonance imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of bleb structure
Key secondary outcomes
correlation between bleb structure and intraocular pressure.
correlation between bleb volume and intraocular pressure.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
take a simple MRI
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
patients who underwent baerveldt glaucoma implantation.
Key exclusion criteria
patients with contraindications for MRI including cardiac pacemakers, presence of tattoos or metal in their bodies, ore pregnancy.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwasaki |
Organization
Faculty of Medical Sciences,
University of Fukui
Division name
Department of Ophthalmology
Zip code
9101106
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-8403
fganka@med.u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Iwasaki |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Ophthalmology
Zip code
9101106
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-8403
Homepage URL
fganka@med.u-fukui.ac.jp
Sponsor or person
Institute
Ministry of education
Institute
Department
Personal name
Funding Source
Organization
Abbott Medical Optics, Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medical Sciences, University of Fukui
Address
23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
Tel
0776-61-8529
smsien-k@ad.u-fukui.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
| 2017 | Year | 10 | Month | 26 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 24 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033927
