UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006008 |
|---|---|
| Receipt number | R000007075 |
| Scientific Title | Prospective investigation of prognostic factors for failure of glaucoma surgeries. |
| Date of disclosure of the study information | 2011/07/21 |
| Last modified on | 2017/01/24 13:25:16 |
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Basic information
Public title
Prospective investigation of prognostic factors for failure of glaucoma surgeries.
Acronym
Investigation of glaucoma-surgery results.
Scientific Title
Prospective investigation of prognostic factors for failure of glaucoma surgeries.
Scientific Title:Acronym
Investigation of glaucoma-surgery results.
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify prognostic risk factors for failure of glaucoma surgeries.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intraocular pressure, surgical complications.
Key secondary outcomes
visual acuity, visual field.
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
glaucoma 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
Patients who will undergo a glaucoma surgery at Kumamoto University Hospital.
Key exclusion criteria
Age <20 years old, patients with a mental disease, patients with ocular diseases (such as corneal opacity) that interrupt ocular examinations, and patients who are considerd inappropriate by the doctor in charge.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenobu Tanihara |
Organization
Kumamoto University
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5247
tanihara@pearl.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Inoue |
Organization
Kumamoto University
Division name
Deparment of Ophthalmology
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto city
TEL
096-373-5247
Homepage URL
noel@da2.so-net.ne.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2011 | Year | 07 | Month | 21 | 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
Main results already published
Date of protocol fixation
| 2011 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 20 | Day |
Last modified on
| 2017 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007075
