UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008680 |
|---|---|
| Receipt number | R000010199 |
| Scientific Title | Postoperative complications of trabeculectomy with mitomycin C versus Ex-Press Mini Glaucoma Shunt implantation with mitomycin C |
| Date of disclosure of the study information | 2012/08/15 |
| Last modified on | 2022/02/19 17:09:56 |
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Basic information
Public title
Postoperative complications of trabeculectomy with mitomycin C versus Ex-Press Mini Glaucoma Shunt implantation with mitomycin C
Acronym
Postoperative complications of trabeculectomy versus mini-shunt
Scientific Title
Postoperative complications of trabeculectomy with mitomycin C versus Ex-Press Mini Glaucoma Shunt implantation with mitomycin C
Scientific Title:Acronym
Postoperative complications of trabeculectomy versus mini-shunt
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The comparison of postoperative complications between trabeculectomy versus mini-shunt
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal endothelial cells, hyphema, choroidal detachment, flat anterior chamber, cataract progression, anterior chamber inflammation
Key secondary outcomes
Bleb morphology, intraocular pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Trabeculectomy with mitomycin C
Interventions/Control_2
Ex-press Mini Glaucoma Shunt implantation with mitomycin C
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
Phakic open-angle glaucoma eyes that have never undergone vitrectomy
Intraocular pressure of 18 mm Hg with anti-glaucoma medication.
Key exclusion criteria
History of previous glaucoma surgery
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Inatani |
Organization
University of Fukui
Division name
Department of Ophthalmology
Zip code
Address
910-1193 Japan
TEL
0776-61-8403
inatani@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaru Inatani |
Organization
University of Fukui
Division name
Department of Ophthalmology
Zip code
Address
23-3 Matsuoka Shimoaizuki Fukui
TEL
0776-61-8403
Homepage URL
inatani@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
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 | 08 | Month | 15 | 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 | 08 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 13 | Day |
Last modified on
| 2022 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010199
