UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021063 |
|---|---|
| Receipt number | R000024039 |
| Scientific Title | Prospective Study on Postoperative Results of Glaucoma Filtration Surgery with Mitomycin C |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2018/02/17 09:19:37 |
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Basic information
Public title
Prospective Study on Postoperative Results of Glaucoma Filtration Surgery with Mitomycin C
Acronym
Prospective Study on Glaucoma Filtration Surgery with Mitomycin C
Scientific Title
Prospective Study on Postoperative Results of Glaucoma Filtration Surgery with Mitomycin C
Scientific Title:Acronym
Prospective Study on Glaucoma Filtration Surgery with Mitomycin C
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the satefy, efficacy, and influencing factors for postoperative results of glaucoma fliltration surgery with Mitomycin C
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intraocular pressure
the frequency and the content of adverse events
Key secondary outcomes
visual acuity
visual field
optical coherence tomography
corneal endothelial cells
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
| Medicine |
Interventions/Control_1
Glaucoma filtration surgery with Mitomycin C
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who require glaucoma filtration surgery
Subjects who sign an informed consent form to participate in the clinical study
Key exclusion criteria
Subjects who a doctor in attendance declares ineligible for any reason
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akitaka Tsujikawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3248
eye@med.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanori Kameda |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Sciences
Zip code
Address
54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3727
Homepage URL
eye@med.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Management Expenses Grants
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
| 2016 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 02 | 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
Management information
Registered date
| 2016 | Year | 02 | Month | 16 | Day |
Last modified on
| 2018 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024039
