UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008156 |
|---|---|
| Receipt number | R000009605 |
| Scientific Title | The efficacy and safety of the Ex-PRESS Glaucoma shunt surgery: a prospective cohort study |
| Date of disclosure of the study information | 2012/06/14 |
| Last modified on | 2016/06/14 11:41:23 |
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Basic information
Public title
The efficacy and safety of the Ex-PRESS Glaucoma shunt surgery: a prospective cohort study
Acronym
The efficacy and safety of the Ex-PRESS Glaucoma shunt surgery: a prospective cohort study
Scientific Title
The efficacy and safety of the Ex-PRESS Glaucoma shunt surgery: a prospective cohort study
Scientific Title:Acronym
The efficacy and safety of the Ex-PRESS Glaucoma shunt surgery: a prospective cohort study
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the efficacy and safety of the EX-PRESS Glaucoma filtration Device surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular 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
Subjects who had a diagnosis of glaucoma that could not be controlled with maximal-tolerated medical therapy and the surgeon diagnosed The EX-PRESS glaucoma filtration devise surgery as the best surgery for the subjects.
Key exclusion criteria
Subjects who do not want to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miho Sugita |
Organization
Sugita Eye Hospital
Division name
Ophthalmology
Zip code
Address
Sakae, 5-1-30, Nakaku, Nagoya
TEL
08048868800
yukikenya114@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenya Yuki |
Organization
Sugita Eye Hospital
Division name
Ophthalmology
Zip code
Address
Sakae, 5-1-30, Nakaku, Nagoya
TEL
052-251-6571
Homepage URL
yukikenya114@gmail.com
Sponsor or person
Institute
Sugita Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
Sugita Eye Hospital
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
| 2012 | Year | 06 | Month | 14 | 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
| 2012 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
Intraocular pressure measurement, best corrected visual acuity, slit lamp biomicroscopy, visual field testing, anterior segment OCT, specular microscopy and fundscopy will be performed pre- and post-operatively for at least 6 months.
Management information
Registered date
| 2012 | Year | 06 | Month | 13 | Day |
Last modified on
| 2016 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009605
