UMIN-CTR Clinical Trial

Basic information
Public title	Comparative study of suture trabeculotomy ab interno by the difference of incision width: 180-degree vs 360-degree Prospective, randomized and comparative study
Acronym	Comparative study of suture trabeculotomy ab interno by the difference of incision width
Scientific Title	Comparative study of suture trabeculotomy ab interno by the difference of incision width: 180-degree vs 360-degree Prospective, randomized and comparative study
Scientific Title:Acronym	Comparative study of suture trabeculotomy ab interno by the difference of incision width
Region	Japan

Condition
Condition	glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of suture trabeculotomy ab interno by the difference of incision width.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraocular pressure and number of glaucomatous medications in postoperative one year.
Key secondary outcomes	complications

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
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
Interventions/Control_2	180-degree suture trabeculotomy ab interno
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	Patients with glaucoma to treat by suture trabeculotomy ab interno.
Key exclusion criteria	none
Target sample size	50

Research contact person
Name of lead principal investigator	1st name TOMOKI Middle name Last name SATO
Organization	Sato Eye and Internal Medicine Clinic
Division name	Department of ophthalmology
Zip code	8640041
Address	4160-270 Arao, Arao City, Kumamoto
TEL	0968-65-5900
Email	zxsato@gmail.com

Public contact
Name of contact person	1st name TOMOKI Middle name Last name SATO
Organization	Sato Eye and Internal Medicine Clinic
Division name	Department of ophthalmology
Zip code	8640041
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)

IRB Contact (For public release)
Organization	Sato Eye and Intermedicine Clinic
Address	4160-270, Arao, Arao City, Kumamoto
Tel	0968655900
Email	zxsato@gmail.com

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 02 Month 25 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	100
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	Completed
Date of protocol fixation	2015 Year 08 Month 01 Day
Date of IRB	2015 Year 08 Month 31 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 24 Day
Last modified on	2021 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024363