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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001196
Receipt No. R000001460
Scientific Title Surgical outcome of trabeculectomy: phakia versus pseudophakia
Date of disclosure of the study information 2008/06/18
Last modified on 2011/12/17

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Basic information
Public title Surgical outcome of trabeculectomy: phakia versus pseudophakia
Acronym Trabeculectomy: phakia versus pseudophakia
Scientific Title Surgical outcome of trabeculectomy: phakia versus pseudophakia
Scientific Title:Acronym Trabeculectomy: phakia versus pseudophakia
Region
Japan

Condition
Condition Patients with primary open-angle glaucoma, or patients with exfoliation glaucoma.
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether the past-history of cataract surgery affects surgical outcomme of trabeculectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Intraocular pressure after trabeculectomy
Key secondary outcomes Bleb formation

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Patients with glaucoma who do not have the past-history of phacoemulsification are treated with trabeculectomy.
Interventions/Control_2 Patients with glaucoma who do have the past-history of phacoemulsification are treated with trabeculectomy.
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
55 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with primary open-angle glaucoma or exfoliation glaucoma.
Intraocular pressure levels of higher than 21 mmHg before trabeculectomy.
Key exclusion criteria Patients who have been previously treated with trabeculectomy.
Patients who have been treated with intraocular surgeries other than phacoemulsification.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Inatani
Organization Kumamoto University Graduate School of Medical Sciences
Division name Department of Ophthalmology and Visual Science
Zip code
Address 1-1-1 Honjo Kumamoto, 860-8556 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kumamoto University Graduate School of Medical Sciences
Division name Department of Ophthalmology and Visual Science
Zip code
Address 1-1-1 Honjo, Kumamoto, 860-8556 Japan
TEL
Homepage URL
Email

Sponsor
Institute Kumamoto University
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
2008 Year 06 Month 18 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
2008 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 06 Month 17 Day
Last modified on
2011 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001460

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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