UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002816
Receipt No. R000003428
Scientific Title Study of glaucoma surgery and intraocular pressure
Date of disclosure of the study information 2009/11/30
Last modified on 2014/05/30

* 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 Study of glaucoma surgery and intraocular pressure
Acronym glaucoma trabeculectomy trial
Scientific Title Study of glaucoma surgery and intraocular pressure
Scientific Title:Acronym glaucoma trabeculectomy trial
Region
Japan

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

Objectives
Narrative objectives1 The goal of this study was to identify the conditions of the preoperative and early postoperative intraocular pressure that predict the lower pressure control in a trabeculectomy with mitomycin C (MMC).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the lower pressure control in a trabeculectomy,preoperative and early postoperative intraocular pressure
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
39 years-old <=
Age-upper limit
88 years-old >=
Gender Male and Female
Key inclusion criteria This study retrospectively analyzed the medical records of the initial trabeculectomy with MMC in surgically treated Japanese patients with primary open-angle glaucoma who had used multiple medications before undergoing the operation from january 2007 to march 2008.
Key exclusion criteria patients who had the trabeculotomy in the past
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Kiuchi
Organization Graduate School of Biomedical Sciences, Hiroshima University
Division name Department of Ophthalmology and Visual science
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5247
Email okimoto@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Okimoto
Organization Graduate School of Biomedical Sciences, Hiroshima University
Division name Department of Ophthalmology and Visual science
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5247
Homepage URL
Email okimoto@hiroshima-u.ac.jp

Sponsor
Institute Department of Ophthalmology and Visual science, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department

Funding Source
Organization Department of Ophthalmology and Visual science, Graduate School of Biomedical Sciences, Hiroshima University
Organization
Division
Category of Funding Organization
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 広島大学病院

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 30 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
2007 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The patients were divided into three groups based on their preoperative IOP; from 11 mmHg to 15 mmHg;from 16 mmHg to 19 mmHg; and over 20mmHg. The appropriate preoperation IOP and that 2 weeks after surgery were examined using Kaplan-Meier survival analyses.

Management information
Registered date
2009 Year 11 Month 30 Day
Last modified on
2014 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003428

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.