UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.
Title of the study (Brief title)	Study on the effect of cataract surgery on the visual acuity, spherical equivalent, intraocular pressure after trabeculectomy.
Region	Japan

Condition
Condition	primary open angle glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of cataract surgery on visual acuity, spherical equivalent and intraocular pressure on the eye after trabeculectomy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual acuity spherical equivalent intraocular pressure
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Intervention for spherical equivalent examination. Five interventions about 1 week, about 1 month, about 3 months, about 6 months, about 1 year later.
Interventions/Control_2	Intervention for eye axis length examination. Five interventions about 1 week, about 1 month, about 3 months, about 6 months, about 1 year later.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	primary open angle glaucoma after trabeculectomy no eye surgery(control) the need for surgery surgery noly PEA+IOL
Key exclusion criteria	other than primary open angle glaucoma In the study group, patients with ophthalmologic surgical history other than trabeculectomy patients with ophthalmologic surgery history in the control group patients with other eye disease
Target sample size	80

Research contact person
Name of lead principal investigator	RYU IIKAWA
Organization	Niigata university
Division name	Ophthalmology
Address	Niigata-city Chuo-ku Asahimachidori 1-757
TEL	025-223-6161
Email	ryu.iikawa@gmail.com

Public contact
Name of contact person	RYU IIKAWA
Organization	Niigata university
Division name	Ophthalmology
Address	Niigata-city Chuo-ku Asahimachidori 1-757
TEL	025-223-6161
Homepage URL
Email	ryu.iikawa@gmailcom

Sponsor
Institute	Niigata university
Institute
Department

Funding Source
Organization	Niigata 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	2017 Year 10 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 08 Month 29 Day
Anticipated trial start date	2017 Year 10 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	2017 Year 09 Month 12 Day
Last modified on	2017 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033300