UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008981
Receipt number R000009329
Scientific Title Prospective comparative study of the Ex-PRESS mini glaucoma shunt with standard trabeculectomy.
Date of disclosure of the study information 2012/09/25
Last modified on 2021/08/12 15:00:47

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Basic information

Public title

Prospective comparative study of the Ex-PRESS mini glaucoma shunt with standard trabeculectomy.

Acronym

Efficacy of Ex-PRESS miniature glaucoma implant

Scientific Title

Prospective comparative study of the Ex-PRESS mini glaucoma shunt with standard trabeculectomy.

Scientific Title:Acronym

Efficacy of Ex-PRESS miniature glaucoma implant

Region

Japan


Condition

Condition

Open angle glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of Ex-PRESS mini shunt on Japanese glaucoma patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

IOP reduction

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Standard trabeculectomy

Interventions/Control_2

Trabeculectomy with Ex-PRESS mini shunt implantation

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

Patients with open angle glaucoma

Key exclusion criteria

Angle-closure glaucoma
Uveitis

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yoshiaki
Middle name
Last name KIUCHI

Organization

Hiroshima University

Division name

Dept. of Ophthahlmology

Zip code

7348551

Address

1-2-3 Kasumi Minamiku Hiroshima

TEL

082-257-5247

Email

ykiuchi@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Kana
Middle name
Last name Tokumo

Organization

Hiroshima University

Division name

Dept. of Ophthalmology

Zip code

7348551

Address

1-2-3 Kasumi Minamiku Hiroshima

TEL

082-257-5247

Homepage URL


Email

kanatokumo@hiroshima-u.ac.jp


Sponsor or person

Institute

Dept. of Ophthalmology
Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Clinical Research Center in Hiroshima

Address

1-2-3 Kasumi Minamiku Hiroshima

Tel

0822575555

Email

protocol@cimr.hiroshima-u.ac.jp


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

2012 Year 09 Month 25 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

2012 Year 05 Month 14 Day

Date of IRB

2012 Year 08 Month 30 Day

Anticipated trial start date

2012 Year 10 Month 01 Day

Last follow-up date

2021 Year 08 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 09 Month 25 Day

Last modified on

2021 Year 08 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009329


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name