UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000434 |
|---|---|
| Receipt number | R000000528 |
| Scientific Title | Comparison of the results after trabeculectomy or cataract surgery in primary angle closure : A non-randomized controlled trial. |
| Date of disclosure of the study information | 2006/07/01 |
| Last modified on | 2014/12/22 14:14:05 |
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Basic information
Public title
Comparison of the results after trabeculectomy or cataract surgery in primary angle closure : A non-randomized controlled trial.
Acronym
Comparison of the results after trabeculectomy or cataract surgery in primary angle closure.
Scientific Title
Comparison of the results after trabeculectomy or cataract surgery in primary angle closure : A non-randomized controlled trial.
Scientific Title:Acronym
Comparison of the results after trabeculectomy or cataract surgery in primary angle closure.
Region
| Japan |
Condition
Condition
Primary angle closure
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By examining the effect and safety of trabeculectomy or cataract surgery, which is better will be determined in the treatment for primary angle closure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative intraocular pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Trabeculectomy
Interventions/Control_2
Cataract surgery
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Primary angle closure patients with the intraocular pressure of 22mmHg or higher after laser iridectomy or surgical peripheral iridectomy, with two or more antiglaucomatous ophthalmic solutions.
2.Written informed consent from the patient.
Key exclusion criteria
1.The patients who have been treated with intraocular surgery.(Expect for PI)
2.Judged inappropriate for this study by the physicians.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Inatani |
Organization
Kumamoto University Graduate School of Medical Sciencies
Division name
Department of Opthalmology and Visual Science
Zip code
Address
1-1-1 Honjo Kumamoto,860-8556
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 Opthalmology
Zip code
Address
23-3 Shimoaizuki Matsuoka Eiheiji Yoshida Fukui
TEL
0776-61-8403
Homepage URL
inatani@u-fukui.ac.jp
Sponsor or person
Institute
Department of Opthalmology and Visual Science, Kumamoto University Gradulate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2006 | Year | 07 | 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
Completed
Date of protocol fixation
| 2006 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 06 | Month | 22 | Day |
Last modified on
| 2014 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000528
