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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014734
Receipt No. R000017127
Scientific Title Clinical results of Trabectome for open-angle glaucoma
Date of disclosure of the study information 2014/08/01
Last modified on 2014/08/01

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Basic information
Public title Clinical results of Trabectome for open-angle glaucoma
Acronym CRTO
Scientific Title Clinical results of Trabectome for open-angle glaucoma
Scientific Title:Acronym CRTO
Region
Japan

Condition
Condition primary open-angle glaucoma, Exfoliation glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine outcomes of Trabectome and evaluate factors associated with the effects for primary open-angle glaucoma and exfoliation glaucoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1: Intraocular pressure
2: Kaplan-Meier survival curve
3: Frequency of the complications
Key secondary outcomes 1: postoperative medication number

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
Maneuver
Interventions/Control_1 Trabectome surgery
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1:Patients with primary open-angle glaucoma and exfoliation glaucoma.
2:Patients who provided written informed consent for participating in this study.
Key exclusion criteria 1:Angle-closure glaucoma
2:secondary glaucoma
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Mizoguchi
Organization Mizoguchi Eye Clinic
Division name Ophthalmology
Zip code
Address 6-13 Tawara-machi Sasebo Nagasaki Japan
TEL 0956-22-5681
Email t-mizo@siren.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanori Mizoguchi
Organization Mizoguchi Eye Clinic
Division name Ophthalmology
Zip code
Address 6-13 Tawara-machi Sasebo Nagasaki Japan
TEL 0956-22-5681
Homepage URL
Email t-mizo@siren.ocn.ne.jp

Sponsor
Institute Mizoguchi Eye Clinic
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nishigaki Eye Clinic
Name of secondary funder(s) No

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 溝口眼科、西垣眼科

Other administrative information
Date of disclosure of the study information
2014 Year 08 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 No longer recruiting
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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
2014 Year 08 Month 01 Day
Last modified on
2014 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017127

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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