UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022926
Receipt number R000026418
Scientific Title A study of the preoperative factor affecting the results of trabeculectomy
Date of disclosure of the study information 2016/06/30
Last modified on 2016/06/28 14:25:00

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Basic information

Public title

A study of the preoperative factor affecting the results of trabeculectomy

Acronym

A study of the preoperative factor affecting trabeculectomy

Scientific Title

A study of the preoperative factor affecting the results of trabeculectomy

Scientific Title:Acronym

A study of the preoperative factor affecting trabeculectomy

Region

Japan


Condition

Condition

Glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A study of the preoperative factor affecting the results of trabeculectomy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postoperative results(IOP)

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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Those who underwent Trabculectomy at Okayama University Hospital
Possible routine visit to a clinic
Possible obtain patient's consent

Key exclusion criteria

In case that the informed consent was not obtained.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naito Tomoko

Organization

Okayama University

Division name

Ophthalmology

Zip code


Address

2-5-1, Shikata-Cho, Kita-Ku, Okayama, Japan

TEL

81-86-235-7297

Email

opth@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Miki Takako

Organization

Okayama University

Division name

Ophthalmology

Zip code


Address

2-5-1, Shikata-Cho, Kita-Ku, Okayama, Japan

TEL

81-86-235-7297

Homepage URL


Email

opth@cc.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



Funding Source

Organization

Okayama University

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2016 Year 06 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

Enrolling by invitation

Date of protocol fixation

2016 Year 05 Month 09 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 09 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

object:Patients who meet the criteria between Apr.2014 and Dec. 2017.


Management information

Registered date

2016 Year 06 Month 28 Day

Last modified on

2016 Year 06 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026418


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name