UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of safety and effectiveness regarding intraocular cyclophotocoagulation for refractory glaucoma
Title of the study (Brief title)	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	Hiroyuki Sato
Organization	Sato Yuya Eye Clinic
Division name	Sato Yuya Eye Clinic
Address	1-6-23 Itsutsubashi, Aoba-ku, Sendai city, Miyagi
TEL	022-227-6752
Email	sato@chukyogroup.jp

Public contact
Name of contact person	Hiroyuki Sato
Organization	Sato Yuya Eye Clinic
Division name	Sato Yuya Eye Clinic
Address	1-6-23 Itsutsubashi, Aoba-ku, Sendai city, Miyagi
TEL	022-227-6752
Homepage URL
Email	sato@chukyogroup.jp

Sponsor
Institute	Sato Yuya Eye Clinic
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031052