UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A retrospective observational study on the evaluation of Trabectome by aqueous humor outflow
Title of the study (Brief title)	A retrospective study on the evaluation of Trabectome by aqueous flow
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the effectiveness of Trabectome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Aqueous humor outflow Intraocural pressure
Key secondary outcomes

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	Not applicable
Gender	Male and Female
Key inclusion criteria	primary open-angle glaucoma
Key exclusion criteria	pterygium, pinguecula or any condition which might interfere with the observation of aqueous humor flow in the eye.
Target sample size	70

Research contact person
Name of lead principal investigator	Toshihiko Ueda
Organization	Nihonmatsu Eye Hospital
Division name	ophthalmology
Address	4-10-7 Hirai Edogawa-ku,Tokyo, Japan
TEL	03-3681-1257
Email	ueda@nihonmatsu.net

Public contact
Name of contact person	Toshihiko Ueda
Organization	Nihonmatsu Eye Hospital
Division name	ophthalmology
Address	4-10-7 Hirai Edogawa-ku,Tokyo, Japan
TEL	03-3681-1257
Homepage URL
Email	ueda@nihonmatsu.net

Sponsor
Institute	Nihonmatsu Eye Hospital
Institute
Department

Funding Source
Organization	none
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	2018 Year 03 Month 16 Day

Progress
Recruitment status	Completed
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	Published
URL releasing results
Results
Other related information	There was a significant correlation between an increase in the composite AHO score and a decrease in IOP after trabectome.

Management information
Registered date	2018 Year 03 Month 15 Day
Last modified on	2018 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036244