UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006522
Receipt No. R000006036
Scientific Title Efficacy and Complications of fornix-based trabeculectomy with Mitomycin C
Date of disclosure of the study information 2011/11/01
Last modified on 2014/04/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy and Complications of fornix-based trabeculectomy with Mitomycin C
Acronym Postoperative record of trabeculectomy
Scientific Title Efficacy and Complications of fornix-based trabeculectomy with Mitomycin C
Scientific Title:Acronym Postoperative record of trabeculectomy
Region
Japan

Condition
Condition glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and complications of trabeculectomy with a single uniform way
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes reduction of intraocular pressure
Key secondary outcomes complications
bleb formation

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 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 The case that trabeculectomy is needed for treatment
Key exclusion criteria The case that already have had trabeclectomy once or more
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Aihara
Organization Tokyo University Hospital
Division name Department of Ophthalmology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL 03-3815-5411
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuka Aoyama
Organization Tokyo University Hospital
Division name Department of Ophthalmology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL 03-3815-5411
Homepage URL
Email yaoyama-tky@umin.ac.jp

Sponsor
Institute Tokyo University Hospital
Institute
Department

Funding Source
Organization Tokyo University Hospital Department of Ophthalmology
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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2014 Year 04 Month 12 Day
Date of closure to data entry
2014 Year 04 Month 12 Day
Date trial data considered complete
2014 Year 04 Month 12 Day
Date analysis concluded
2014 Year 04 Month 12 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 11 Day
Last modified on
2014 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006036

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.