UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of conjunctival incision in trabeculectomy for open-angle glaucoma eyes; limbus-based versus fornix-based.
Title of the study (Brief title)	Limbus-based versus fornix-based
Region	Japan

Condition
Condition	Open-angle glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The impact of conjunctival incision
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraocular pressure
Key secondary outcomes	Bleb morphology

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Limbus-based conjunctival incision
Interventions/Control_2	Fornix-based conjunctival incision
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Open-angle glaucoma eyes with pseudophakia Intraocular pressure of 18 mm Hg with anti-glaucoma medication.
Key exclusion criteria	History of previous glaucoma surgery
Target sample size	100

Research contact person
Name of lead principal investigator	Masaru Inatani
Organization	University of Fukui
Division name	Department of Ophthalmology
Address	910-1193 Japan
TEL	0776618403
Email	inatani@u-fukui.ac.jp

Public contact
Name of contact person	Masaru Inatani
Organization	University of Fukui
Division name	Department of Ophthalmology
Address	910-1193 Japan
TEL	0776-61-8403
Homepage URL
Email	inatani@u-fukui.ac.jp

Sponsor
Institute	University of Fukui
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization
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	2012 Year 03 Month 29 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 02 Month 27 Day
Anticipated trial start date	2012 Year 03 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 03 Month 05 Day
Last modified on	2016 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000008777