UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027734 |
|---|---|
| Receipt number | R000031775 |
| Scientific Title | A Randomized Study of Efficacy of trabecular micro bypass stent with cataract surgery for open angle glaucoma |
| Date of disclosure of the study information | 2017/06/12 |
| Last modified on | 2020/09/09 19:06:32 |
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Basic information
Public title
A Randomized Study of Efficacy of trabecular micro bypass stent with cataract surgery for open angle glaucoma
Acronym
The Efficacy of iStent
Scientific Title
A Randomized Study of Efficacy of trabecular micro bypass stent with cataract surgery for open angle glaucoma
Scientific Title:Acronym
The Efficacy of iStent
Region
| Japan |
Condition
Condition
primary open angle glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to reveal the efficacy of iStent
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intra ocular pressure post cataract-operative 1.2.3.6.12months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
to insult the iStent during cataract surgeries
Interventions/Control_2
not to insult the iStent during cataract surgeries
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
Key inclusion criteria
a
Key exclusion criteria
a
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kiuchi |
Organization
Hiroshima Univ.Graduate school
Division name
Biomedical Science of Ophthalmology and visual science
Zip code
Address
1-2-3 kasumi,minamiku,hiroshima
TEL
0822575247
Ykiuchi@hiroshma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shun Masuda |
Organization
Hiroshima Univ.Graduate school
Division name
Biomedical Science of Ophthalmology and visual science
Zip code
Address
1-2-3 kasumi,minamiku,hiroshima
TEL
0822575247
Homepage URL
masudash@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima Univ.
Institute
Department
Personal name
Funding Source
Organization
Glaukos
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
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
| 2017 | Year | 06 | Month | 12 | 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
| 2017 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 09 | 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
| 2017 | Year | 06 | Month | 12 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031775
| 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 |
