UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002816
Receipt number 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 13:59:07

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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