UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003849 |
|---|---|
| Receipt number | R000004636 |
| Scientific Title | Prospective randomized comparison of phacoemulsification and phacoemulsification with goniosynechialysis in patients with primary angle closure |
| Date of disclosure of the study information | 2010/07/01 |
| Last modified on | 2010/06/30 17:46:31 |
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Basic information
Public title
Prospective randomized comparison of phacoemulsification and phacoemulsification with goniosynechialysis in patients with primary angle closure
Acronym
Phaco-GSL study
Scientific Title
Prospective randomized comparison of phacoemulsification and phacoemulsification with goniosynechialysis in patients with primary angle closure
Scientific Title:Acronym
Phaco-GSL study
Region
| Japan | Asia(except Japan) |
Condition
Condition
primary angle closure, primary angle closure glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of phacoemulsification and phacoemulsification with goniosynechialysis for chronic primary angle closure and primary angle closure glaucoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
intraocular pressure
Key secondary outcomes
iridotraecular contact
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
phacoemulicification and goniosynechialysis
Interventions/Control_2
phacoemulicification
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Primary angle closure and primary angle closure glaucoma
2) Existence of peripheral anterior synechiae (25% or more)
3) Existence of cataract (grade 2 or more)
Key exclusion criteria
1) Nanophthalmos (Axial length < 20 mm)
2) Advanced glaucomatous visual field loss (HFA, MD<-15dB)
3) Difficulty of IOP measurement
4) History of glaucoma surgery except laser iridotomy
5) History of cataract surgery
6) History of refractive surgery
7) Active ocular diseases (inflammatory, infectious)
8) Pregnancy or its suspect
9) Breast-feeding
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidenobu Tanihara |
Organization
Kumamoto University
Division name
Ophthalmology
Zip code
Address
2-39-1 Kurokami, Kumamoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sakai |
Organization
University of the Ryukyus
Division name
Ophthalmology
Zip code
Address
TEL
Homepage URL
hi-hiro@mtf.biglobe.ne.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
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
| 2010 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | 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
Management information
Registered date
| 2010 | Year | 06 | Month | 30 | Day |
Last modified on
| 2010 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004636
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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