UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the retinal and choroidal thickness after trabeculectomy
Title of the study (Brief title)	Retinal and choroidal thickness after trabeculectomy
Region	Japan

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

Objectives
Narrative objectives1	The aim of the study is to investigate the effect of the trabeculectomy for the retinal and choroidal thickness in primary open angle glaucoma patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraocular pressure, Retinal thickness, Choroidal thickness
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	Maneuver
Interventions/Control_1	trabeculectomy
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with glaucoma resistance to topical glaucoma medications.
Key exclusion criteria	1 Pregnant woman 2 Patients with cataract
Target sample size	50

Research contact person
Name of lead principal investigator	Shunsuke Nakakura
Organization	Saneikai Tsukazaki Hospital
Division name	Department of Ophthalmology
Address	Himeji City, Aboshi Waku 68-1
TEL	079-272-8555
Email	shunsukenakakura@yahoo.co.jp

Public contact
Name of contact person	Shunsuke Nakakura
Organization	Saneikai Tsukazaki Hospital
Division name	Department of Ophthalmology
Address	Saneikai Tsukazaki Hospital
TEL	079-272-8555
Homepage URL
Email	shunsukenakakura@yahoo.co.jp

Sponsor
Institute	Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization	Saneikai Tsukazaki Hospital
Organization
Division
Category of Funding Organization	Other
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	2013 Year 07 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 09 Day
Anticipated trial start date	2013 Year 07 Month 09 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	In sufficient of Patients.
Other related information	None

Management information
Registered date	2013 Year 07 Month 09 Day
Last modified on	2017 Year 01 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013063