UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011989 |
|---|---|
| Receipt number | R000014010 |
| Scientific Title | Retrospective study of clinical evaluation on Trabectome surgery |
| Date of disclosure of the study information | 2013/10/10 |
| Last modified on | 2014/04/08 12:57:11 |
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Basic information
Public title
Retrospective study of clinical evaluation on Trabectome surgery
Acronym
Retrospective study of clinical evaluation on Trabectome surgery
Scientific Title
Retrospective study of clinical evaluation on Trabectome surgery
Scientific Title:Acronym
Retrospective study of clinical evaluation on Trabectome surgery
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To report the postoperative results of Trabectome surgery performed at Kitasato University Hospital including the effect of intraocular pressure(IOP) drops and the frequency of complications. And to evaluate the influences of Trabectome surgery on the results of trabeculectomy in case that the effectiveness of Trabectome surgery on the reduction of IOP is insufficient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
*Age
*Gender
*Visual Acuity(Refraction): Distant Visual Acuity
*Intraocular Pressure:measured by Goldmann applanation tonometer
*General ophthalmologic examination: Slit-lamp microscopy, gonioscopic examination and Ophthalmoscopy
*Visual field: Humphrey Field Analyzer or Goldmann perimeter
*Cell density of Corneal endothelium
*The number of anti-glaucomatous medications
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
Those who underwent Trabectome surgery at Kitasato University Hospital between December 2010 to June 2013 are eligible.
Key exclusion criteria
In case that the informed consent was not obtained.
Target sample size
117
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shoji |
Organization
Kitasato University, School of Allied Health Science
Division name
Department of Rehabilitation, Orthoptics and Visual Science
Zip code
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa Japan
TEL
042-778-9679
nshoji@ahs.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Shoji |
Organization
Kitasato University, School of Allied Health Science
Division name
Department of Rehabilitation, Orthoptics and Visual Science
Zip code
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa Japan
TEL
042-778-9679
Homepage URL
nshoji@ahs.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology,
Kitasato University Hospital
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
北里大学病院（神奈川県） Kitasato University Hospital(Kanagawa)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 10 | 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
| 2013 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
We will be announcing the information on World Ophthalmology Congress which will be held in April, 2014. After the congress, it will be documented.
Management information
Registered date
| 2013 | Year | 10 | Month | 08 | Day |
Last modified on
| 2014 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014010
