UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004887 |
|---|---|
| Receipt number | R000005820 |
| Scientific Title | Incidence, risk factor and the effect of flat anterior chamber after trabeculectomy;retrospective study |
| Date of disclosure of the study information | 2011/01/17 |
| Last modified on | 2011/07/17 10:44:06 |
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Basic information
Public title
Incidence, risk factor and the effect of flat anterior chamber after trabeculectomy;retrospective study
Acronym
Incidence, risk factor and the effect of flat anterior chamber after trabeculectomy
Scientific Title
Incidence, risk factor and the effect of flat anterior chamber after trabeculectomy;retrospective study
Scientific Title:Acronym
Incidence, risk factor and the effect of flat anterior chamber after trabeculectomy
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the incidence, risk factor and the long term effect of flat anterior chamber after trabeculectomy with mitomycin C
Basic objectives2
Others
Basic objectives -Others
To investigate the incidence, risk factor and the long term effect of flat anterior chamber after trabeculectomy with mitomycin C
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence, risk factor and intraocular pressure for 5 years after trabeculectomy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All the subjects who underwent trabeculectomy between January 1st 1999 and December 31st 2009.Flat anterior chamber was defined by slit lamp microscopy in the medical record.
Key exclusion criteria
Subjects with flat anterior chamber caused by papillary block after glaucoma surgery, choroidal hemorrhage or by malignant glaucoma were excluded.
Subjects without information of postoperative anterior chamber in the medical record.
Subjects who underwent trabeculectomy combined with IOL suture, vitrectomy or cyclophotocoagulation.
Target sample size
650
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Kenya |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
Shinanomachi 35, Shinjyuku-ku
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Kenya |
Organization
Keio University School of Medicine
Division name
Ophthalmology
Zip code
Address
TEL
Homepage URL
http://www.keio-eye.net/
Sponsor or person
Institute
Keio University School of Medicine, Department of Ophthalmology
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
| 2011 | Year | 01 | Month | 17 | 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
| 2011 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | 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
Consecutive patients that underwent trabeculectomy or phacotrabeculectomy with mitomycin C were evaluated. Flat anterior chamber was divided into three grades. Incidence of flat anterior chamber was evaluated. Risk factor for flat anterior chamber was analyzed by logistic regression model. To identify the hazards rations for the failure of trabeculectomy for 5 years, multivariate Cox proportional hazards regression analysis was performed.
Management information
Registered date
| 2011 | Year | 01 | Month | 17 | Day |
Last modified on
| 2011 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005820
