UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014734 |
|---|---|
| Receipt number | R000017127 |
| Scientific Title | Clinical results of Trabectome for open-angle glaucoma |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2014/08/01 02:50:31 |
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Basic information
Public title
Clinical results of Trabectome for open-angle glaucoma
Acronym
CRTO
Scientific Title
Clinical results of Trabectome for open-angle glaucoma
Scientific Title:Acronym
CRTO
Region
| Japan |
Condition
Condition
primary open-angle glaucoma, Exfoliation glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine outcomes of Trabectome and evaluate factors associated with the effects for primary open-angle glaucoma and exfoliation glaucoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1: Intraocular pressure
2: Kaplan-Meier survival curve
3: Frequency of the complications
Key secondary outcomes
1: postoperative medication number
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
| Maneuver |
Interventions/Control_1
Trabectome 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:Patients with primary open-angle glaucoma and exfoliation glaucoma.
2:Patients who provided written informed consent for participating in this study.
Key exclusion criteria
1:Angle-closure glaucoma
2:secondary glaucoma
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Mizoguchi |
Organization
Mizoguchi Eye Clinic
Division name
Ophthalmology
Zip code
Address
6-13 Tawara-machi Sasebo Nagasaki Japan
TEL
0956-22-5681
t-mizo@siren.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Mizoguchi |
Organization
Mizoguchi Eye Clinic
Division name
Ophthalmology
Zip code
Address
6-13 Tawara-machi Sasebo Nagasaki Japan
TEL
0956-22-5681
Homepage URL
t-mizo@siren.ocn.ne.jp
Sponsor or person
Institute
Mizoguchi Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nishigaki Eye Clinic
Name of secondary funder(s)
No
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
溝口眼科、西垣眼科
Other administrative information
Date of disclosure of the study information
| 2014 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 01 | Day |
Last modified on
| 2014 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017127
