UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031745 |
|---|---|
| Receipt number | R000036244 |
| Scientific Title | A retrospective observational study on the evaluation of Trabectome by aqueous humor outflow |
| Date of disclosure of the study information | 2018/03/16 |
| Last modified on | 2018/03/15 17:48:06 |
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Basic information
Public title
A retrospective observational study on the evaluation of Trabectome by aqueous humor outflow
Acronym
A retrospective study on the evaluation of Trabectome by aqueous flow
Scientific Title
A retrospective observational study on the evaluation of Trabectome by aqueous humor outflow
Scientific Title:Acronym
A retrospective study on the evaluation of Trabectome by aqueous flow
Region
| Japan |
Condition
Condition
Primary open angle glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness of Trabectome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aqueous humor outflow
Intraocural pressure
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
primary open-angle glaucoma
Key exclusion criteria
pterygium, pinguecula or any condition which might interfere with the observation of aqueous humor flow in the eye.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Ueda |
Organization
Nihonmatsu Eye Hospital
Division name
ophthalmology
Zip code
Address
4-10-7 Hirai Edogawa-ku,Tokyo, Japan
TEL
03-3681-1257
ueda@nihonmatsu.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Ueda |
Organization
Nihonmatsu Eye Hospital
Division name
ophthalmology
Zip code
Address
4-10-7 Hirai Edogawa-ku,Tokyo, Japan
TEL
03-3681-1257
Homepage URL
ueda@nihonmatsu.net
Sponsor or person
Institute
Nihonmatsu Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | 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
There was a significant correlation between an increase in the composite AHO score and a decrease in IOP after trabectome.
Management information
Registered date
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036244
