UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012282 |
|---|---|
| Receipt number | R000014301 |
| Scientific Title | Bleb morphology before and after phacoemulsification |
| Date of disclosure of the study information | 2013/11/14 |
| Last modified on | 2016/11/01 12:00:04 |
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Basic information
Public title
Bleb morphology before and after phacoemulsification
Acronym
Bleb morphology before and after phacoemulsification
Scientific Title
Bleb morphology before and after phacoemulsification
Scientific Title:Acronym
Bleb morphology before and after phacoemulsification
Region
| Japan |
Condition
Condition
glaucoma, cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To unveil the bleb-related factors that affect IOP after cataract surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Bleb morphology one month after lens extraction
Key secondary outcomes
Bleb morphology and IOP before and after cataract surgery
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
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who experience trabeculectomy surgery more than one year before cataract surgery
Key exclusion criteria
Uncontrollable IOP
Surgical complication
Target sample size
20
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
Matsuoka Shimoaizuki 23-3, Eiheiji-cho, Fukui
TEL
+81-776-61-8403
inatani@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Yokota |
Organization
University of Fukui
Division name
Department of Ophthalmology
Zip code
Address
Matsuoka Shimoaizuki 23-3, Eiheiji-cho, Fukui
TEL
+81-776-61-8403
Homepage URL
stsykt@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
福井大学医学部附属病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 14 | 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 | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 08 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 08 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Cataract surgery is performed with 2.4 mm temporal corneal incision. After completion of continuous curvilinear capsulorhexis, phacoemulsification and aspiration is done, and IOL is injected in the bag.
Before and after cataract surgery, bleb morphology is recorded with 3D-OCT(SS-1000, TOMEY). On the same day, bleb appearance is recorded by Indiana Bleb Appearance Grading Scale (IBAGS) and IOP is measured with applanation tonometer.
Management information
Registered date
| 2013 | Year | 11 | Month | 13 | Day |
Last modified on
| 2016 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014301
