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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006729
Receipt No. R000007948
Scientific Title To evaluate the effect of phacoemulsification or viscogonioplasty in breaking the peripheral anterior synechia
Date of disclosure of the study information 2011/11/19
Last modified on 2018/11/22

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Basic information
Public title To evaluate the effect of phacoemulsification or viscogonioplasty in breaking the peripheral anterior synechia
Acronym Effect of phacoemulsification and viscogonioplasty for the peripheral anterior synechia
Scientific Title To evaluate the effect of phacoemulsification or viscogonioplasty in breaking the peripheral anterior synechia
Scientific Title:Acronym Effect of phacoemulsification and viscogonioplasty for the peripheral anterior synechia
Region
Japan

Condition
Condition Primary angle closure glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of phacoemulsification or viscogonioplasty in breaking the peripheral anterior synechia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Effect of breaking the peripheral anterior synechia
Key secondary outcomes Intraocular pressure

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Phacoemulsification and intraocular lens implantation
Goniosynechialysis using a heavy viscoelastic
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Patients with cataract
2 Primary angle glaucoma patients with peripheral anterior synechia greater than 180 degree by compression gonioscopy
3 Patients with uncontrolled intraocular pressure
Key exclusion criteria 1 Patients with any retinal diseases or with uveitis
2 Any glaucoma surgery except for peripheral iridotomy or iridectomy
3 Other glaucomas
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Nakakura
Organization Saneikai Tsukazaki Hospital
Division name Ophthalmology
Zip code
Address Himeji City, Aboshi Waku 68-1
TEL +81-79-272-8555
Email shunsukenakakura@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Nakakura
Organization Saneikai Tsukazaki Hospital
Division name Ophthalmology
Zip code
Address Himeji City, Aboshi Waku 68-1
TEL +81-79-272-8555
Homepage URL
Email shunsukenakakura@yahoo.co.jp

Sponsor
Institute Department of Ophthalmology,Saneikai Tsukazaki Hospital
Institute
Department

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
Email

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 11 Month 19 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 11 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 19 Day
Last follow-up date
2014 Year 12 Month 30 Day
Date of closure to data entry
2014 Year 12 Month 30 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2018 Year 11 Month 22 Day

Other
Other related information

Management information
Registered date
2011 Year 11 Month 15 Day
Last modified on
2018 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007948

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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