UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of trabeculectomy on visual disorders progression for glaucoma patients.
Title of the study (Brief title)	The influence of trabeculectomy on visual disorders progression.
Region	Japan

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

Objectives
Narrative objectives1	The effect of surgery is confirmed by comparing the progression of vision disorder before and after filtration surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual field disorder
Key secondary outcomes	intraocular pressure

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	preoperative IOP is under 20mmHg
Key exclusion criteria	Patients have no offer to participate
Target sample size	100

Research contact person
Name of lead principal investigator	Tomoko Naito
Organization	Okayama University
Division name	ophthalmology
Address	2-5-1,Shikata-Cho, Kita-Ku, Okayama, Okayama, Japan
TEL	086-235-7297
Email	opth@cc.okayama-u.ac.jp

Public contact
Name of contact person	Miyuki Fujiwara
Organization	Okayama University
Division name	Ophthalmology
Address	2-5-1,Shikata-Cho, Kita-Ku, Okayama, Okayama, Japan
TEL	086-235-7297
Homepage URL
Email	opth@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	Okayama University
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 11 Month 23 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 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	wanted

Management information
Registered date	2016 Year 11 Month 21 Day
Last modified on	2016 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028679