UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Outcomes of 360-degree suture trabeculotomy ab interno with cataract surgery in patient with open-angle glaucoma coexisting cataract: a 2-year prospective, randomized, comparative study
Title of the study (Brief title)	Outcomes of 360-degree suture trabeculotomy ab interno with cataract surgery
Region	Japan

Condition
Condition	open-angle glaucoma coexisting cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To prospectively examine the safety and efficacy of 360-degree suture trabeculotomy ab interno with cataract surgery in patients with open-angle glaucoma coexisting cataract.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraocular pressure and the number of glaucoma medications.
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	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	360-degree suture trabeculotomy ab interno with cataract surgery
Interventions/Control_2	cataract surgery
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	The patients with open-angle glaucoma coexisting cataract who need cataract surgery.
Key exclusion criteria	Glaucoma except for primary open-angle glaucoma and exfoliation glaucoma.
Target sample size	20

Research contact person
Name of lead principal investigator	Tomoki Sato
Organization	Sato Eye and Internal Medicine Clinic
Division name	Department of ophthalmology
Address	4160-270 Arao, Arao City, Kumamoto
TEL	0968-65-5900
Email	zxsato@gmail.com

Public contact
Name of contact person	Tomoki Sato
Organization	Sato Eye and Internal Medicine Clinic
Division name	Department of ophthalmology
Address	4160-270 Arao, Arao City, Kumamoto
TEL	0968-65-5900
Homepage URL
Email	zxsato@gmail.com

Sponsor
Institute	Sato Eye and Internal Medicine Clinic
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2016 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 31 Day
Anticipated trial start date	2014 Year 02 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 24 Day
Last modified on	2019 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024416