UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002816 |
|---|---|
| Receipt number | R000003428 |
| Scientific Title | Study of glaucoma surgery and intraocular pressure |
| Date of disclosure of the study information | 2009/11/30 |
| Last modified on | 2014/05/30 13:59:07 |
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Basic information
Public title
Study of glaucoma surgery and intraocular pressure
Acronym
glaucoma trabeculectomy trial
Scientific Title
Study of glaucoma surgery and intraocular pressure
Scientific Title:Acronym
glaucoma trabeculectomy trial
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of this study was to identify the conditions of the preoperative and early postoperative intraocular pressure that predict the lower pressure control in a trabeculectomy with mitomycin C (MMC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the lower pressure control in a trabeculectomy,preoperative and early postoperative 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
| 39 | years-old | <= |
Age-upper limit
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This study retrospectively analyzed the medical records of the initial trabeculectomy with MMC in surgically treated Japanese patients with primary open-angle glaucoma who had used multiple medications before undergoing the operation from january 2007 to march 2008.
Key exclusion criteria
patients who had the trabeculotomy in the past
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kiuchi |
Organization
Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Ophthalmology and Visual science
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5247
okimoto@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Okimoto |
Organization
Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Ophthalmology and Visual science
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5247
Homepage URL
okimoto@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual science, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology and Visual science, Graduate School of Biomedical Sciences, Hiroshima University
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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients were divided into three groups based on their preoperative IOP; from 11 mmHg to 15 mmHg;from 16 mmHg to 19 mmHg; and over 20mmHg. The appropriate preoperation IOP and that 2 weeks after surgery were examined using Kaplan-Meier survival analyses.
Management information
Registered date
| 2009 | Year | 11 | Month | 30 | Day |
Last modified on
| 2014 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003428
