UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009848
Receipt number R000011020
Scientific Title The effect of 360-degree suture trabeculotomy on the decrease of intraocular pressure in patients with glaucoma
Date of disclosure of the study information 2013/01/24
Last modified on 2016/07/27 10:21:51

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Basic information

Public title

The effect of 360-degree suture trabeculotomy on the decrease of intraocular pressure in patients with glaucoma

Acronym

The efficacy of 360-degree suture trabeculotomy

Scientific Title

The effect of 360-degree suture trabeculotomy on the decrease of intraocular pressure in patients with glaucoma

Scientific Title:Acronym

The efficacy of 360-degree suture trabeculotomy

Region

Japan


Condition

Condition

glaucoma

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of 360-degree suture trabeculotomy on the decrease of intraocular pressure

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

intraocular pressure

Key secondary outcomes



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

360-degree suture trabeclotomy

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Glaucoma patients resistance to topical glaucoma eye drop treatment

Key exclusion criteria

pregnant woman, breast-feeding woman

High degree of visual field defect (MD value under -20dB in HFA c-30-2)

Paitents with serious systemic or opthalmic complications

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyuki Ohguro

Organization

Japan Community Healthcare Organaization Osaka Hospital

Division name

Ophthalmology

Zip code


Address

4-2-78 Fukushima, Fukushima-ku, Osaka

TEL

06-6441-5451

Email

nohguro@okn.gr.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuyuki Ohguro

Organization

Japan Community Healthcare Organaization Osaka Hospital

Division name

Ophthalmology

Zip code


Address

4-2-78 Fukushima, Fukushima-ku, Osaka

TEL

06-6441-5451

Homepage URL


Email

nohguro@okn.gr.jp


Sponsor or person

Institute

Japan Community Healthcare Organaization Osaka Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Community Healthcare Organaization Osaka Hospital

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



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 24 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

Open public recruiting

Date of protocol fixation

2013 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 16 Day

Last follow-up date

2016 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 01 Month 01 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 01 Month 23 Day

Last modified on

2016 Year 07 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011020


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name