UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027090
Receipt number R000031052
Scientific Title Evaluation of safety and effectiveness regarding intraocular cyclophotocoagulation for refractory glaucoma
Date of disclosure of the study information 2017/04/24
Last modified on 2017/08/29 13:50:43

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Basic information

Public title

Evaluation of safety and effectiveness regarding intraocular cyclophotocoagulation for refractory glaucoma

Acronym

Evaluation of safety and effectiveness regarding intraocular cyclophotocoagulation

Scientific Title

Evaluation of safety and effectiveness regarding intraocular cyclophotocoagulation for refractory glaucoma

Scientific Title:Acronym

Evaluation of safety and effectiveness regarding intraocular cyclophotocoagulation

Region

Japan


Condition

Condition

Refractory terminal glaucoma
Glaucoma absolutum

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate therapeutic effect and safety of cyclophotocoagulation using newly developed prototype laser coaxial probe for refractory and absolute glaucoma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postoperative reduction of 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

Device,equipment Maneuver

Interventions/Control_1

By using endoscopic coaxial laser probe which is unapproved by this country, unapproved surgical technique will be conducted.

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

(1)A case which intraocular pressure is not lowering sufficiently due to medication and multiple glaucoma surgery, and which intraocular pressure reduction by cyclophotocoagulation is most suitable.
(2)A person who is older than 20 years old at the time of agreement, who can obtain consent on written paper, or who is able to obtain consent from one's person in parental authority in case the one is underage.

Key exclusion criteria

(1)A person who is not able to agree to participate in this study.
(2)If principal investigator or a member of the research project determine inappropriate.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyuki Sato

Organization

Sato Yuya Eye Clinic

Division name

Sato Yuya Eye Clinic

Zip code


Address

1-6-23 Itsutsubashi, Aoba-ku, Sendai city, Miyagi

TEL

022-227-6752

Email

sato@chukyogroup.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroyuki Sato

Organization

Sato Yuya Eye Clinic

Division name

Sato Yuya Eye Clinic

Zip code


Address

1-6-23 Itsutsubashi, Aoba-ku, Sendai city, Miyagi

TEL

022-227-6752

Homepage URL


Email

sato@chukyogroup.jp


Sponsor or person

Institute

Sato Yuya Eye Clinic

Institute

Department

Personal name



Funding Source

Organization

Sato Yuya Eye Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

FiberTech Co., Ltd.

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

2017 Year 04 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

2017 Year 04 Month 24 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 04 Month 21 Day

Last modified on

2017 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031052


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name